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Journal Article

Citation

Fed. Regist. 2012; 77(155): 47823-47826.

Copyright

(Copyright © 2012, U.S. Office of the Federal Register, National Archives and Records Service, General Services Administration)

DOI

unavailable

PMID

unavailable

Abstract

Under provisions of its Rules of Practice for Adjudicative Proceeding (16 CFR part 1025), the Consumer Product Safety Commission must publish in the Federal Register Complaints which it issues. Published below is a Complaint: In the Matter of Zen Magnets, LLC. [The Commission voted 3–1 to authorize issuance of this Complaint. Chairman Inez M. Tenenbaum, Commissioner Anne M. Northup and Commissioner Robert S. Adler voted to authorize issuance of the Complaint. Commissioner Nancy A. Nord voted to not authorize issuance of the Complaint.]

SUPPLEMENTARY INFORMATION: The text of the Complaint appears below.

Dated: August 7, 2012. Todd A. Stevenson, Secretary. United States of America Consumer Product Safety Commission CPSC Docket No. 12–2. In the Matter of Zen Magnets, LLC, Respondent.


Complaint


Nature of Proceedings 1. This is an administrative enforcement proceeding pursuant to Section 15 of the Consumer Product Safety Act (''CPSA''), as amended, 15 U.S.C. 2064, for public notification and remedial action to protect the public from the substantial risks of injury presented by aggregated masses of high- powered, small rare earth magnets known as Zen MagnetsTMRare Earth Magnetic Balls, imported and distributed by Zen Magnets, LLC (''Zen'' or ''Respondent'').


2. This proceeding is governed by the Rules of Practice for Adjudicative Proceedings before the Consumer Product Safety Commission (''Commission''), 16 CFR Part 1025. Jurisdiction


3. This proceeding is instituted pursuant to the authority contained in Sections 15(c), (d), and (f) of the CPSA, 15 U.S.C. 2064(c), (d), and (f). Parties


4. Complaint Counsel is the staff of the Division of Compliance within the Office of the General Counsel of the Commission (''Complaint Counsel''). The Commission is an independent federal regulatory agency established pursuant to Section 4 of the CPSA, 15 U.S.C. 2053.


5. Upon information and belief, Zen is a Colorado corporation with its principal place of business located at 4155 E. Jewell Avenue, Suite 908, Denver, Colorado 80222.


6. Respondent is an importer and distributor of the Subject Products known as Zen MagnetsTM.


7. As importer and distributor of the Subject Products, Respondent is a ''manufacturer'' and ''distributor'' of a ''consumer product'' that is ''distributed in commerce,'' as those terms are defined in CPSA sections 3(a)(5), (7), (8), and (11) of the CPSA, 15 U.S.C. 2052(a)(5), (7), (8), and (11).


The Consumer Product 8. The Subject Products are imported and distributed in U.S. commerce and offered for sale to consumers for their personal use in or around a permanent or temporary household or residence, a school, and in recreation or otherwise. The Subject Products consist of small, individual magnets that are packaged as aggregated masses in containers of varying size. These containers hold anywhere from 72 to 1,728 small magnets. Each magnet ranges in size from approximately 5.03 mm, with a chrome coating, and a flux index of over 50.


9. Upon information and belief, the flux index of the Subject Products ranges from 577.1 to 581.4 kg2mm.


10. Upon information and belief, Respondent introduced the Subject Products into U.S. commerce in July 2009.


11. Upon information and belief, the Subject Products are currently manufactured by Bestway Magnet Corp. No. 225, Northern Section of Huancheng Westroad, Ningbo, China.


12. Upon information and belief, Respondent advertised and marketed the product in 2009 and 2010 as ''fun to play with'' strong rare-earth magnets that ''look good on cute people'' and can act as stress relief and a way to relieve boredom.


13. Upon information and belief, in 2011 Respondent began advertising and marketing the product as a ''magnetic science kit'' in addition to the uses listed above.


14. Upon information and belief, the Subject Products are sold in a velvet sack, or an MDF hard case for the sets of 72 and 216 magnets. The larger set of 1,728 magnets is packaged in a velvet- lined wooden teak box. The sets range in retail price from approximately $12.65 to over $250.00 for the largest set.


15. Upon information and belief, more than 57,000 of the Subject Products have been sold to consumers in the United States. The Subject Products Create a Substantial Risk of Injury to the Public


16. The Subject Products pose a risk of magnet ingestion by children under the age of 14, who, consistent with developmentally appropriate behavior, may place single or numerous magnet balls in their mouths. The risk of ingestion also exists when adolescents use the product to mimic piercings of the lip, tongue, and cheek and accidentally swallow the balls.


17. If two or more of the magnets are ingested and their magnetic forces pull them together, the magnets can pinch or trap the intestinal walls or other digestive tissue between them resulting in acute and long-term health consequences. Magnets that attract through the walls of the intestines result in progressive tissue injury, beginning with local inflammation and ulceration, progressing to tissue death, then perforation or fistula formation. Such conditions can lead to infection, sepsis, and death. Ingestion of more than one magnet often requires medical intervention, including endoscopic or surgical procedures. However, because the initial symptoms of injury from magnet ingestion are nonspecific and may include nausea, vomiting, and abdominal pain, caretakers, parents, and medical professionals may easily mistake these nonspecific symptoms for other common gastrointestinal upsets, and erroneously believe that medical treatment is not immediately required.


18. Medical professionals may not be aware of the dangers posed by ingestion of the Subject Products and the corresponding need for immediate evaluation and monitoring. A delay of surgical intervention due to the patient's presentation with nonspecific symptoms and/or a lack of awareness by medical personnel of the dangers posed by multiple magnet ingestion can exacerbate life-threatening internal injuries.


19. Magnets that become affixed through the gastrointestinal walls and are not surgically removed may result in intestinal perforations that can lead to necrosis, the formation of fistulas, or ultimately, perforation of the bowel and leakage of toxic bowel contents into the abdominal cavity. These conditions can lead to serious injury and possibly even death.


20. Endoscopic and surgical procedures may also be complicated in cases of multiple magnet ingestion due to the attraction of the magnet balls to the metal equipment used to retrieve the magnets.


21. Children who undergo surgery to remove multiple magnets from their gastrointestinal tract face long-term health consequences, including intestinal scarring, nutritional deficiencies due to loss of portions of the bowel, and possible fertility issues for women ...

The remaining text is freely available at:
https://www.federalregister.gov/documents/2012/08/10/2012-19693/zen-magnets-llc-complaint


Keywords: Multiple magnet ingestion

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