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Citation
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Whitford M, Mitchell SJ, Marzloff GE, Zindle JK, Richmond MA, Bogie KM, Henzel MK. J. Patient Saf. 2020; ePub(ePub): ePub. |
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Abstract
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OBJECTIVES: The aims of the study were to assess reports of wheelchair mobility-related injuries from inadvertent lower extremity displacement (ILED) on footplates, which were submitted to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database during 2014-2018, characterize injury types, and evaluate MAUDE data quality.
METHODS: A systematic MAUDE database review was performed. Annual reports were searched using keywords: (a) "power wheelchair" and "injury" and (b) "mechanical (also known as manual) wheelchair" and "injury." Reports related to injuries from ILED on the footplate were reviewed.
RESULTS: Reports of 1075 wheelchair injuries were found across the review period. Twenty nine (3%) met our inclusion criteria. The most common source of reports was "manufacturer." The wheelchair was unavailable for evaluation in 55.17% of reports. Manufacturers' submission dates (number of days that passed after they were notified) ranged from 3 to 159. Reported injuries decreased by 60% from 2014 to 2018. The end user used a power wheelchair for all but one report. The most common injuries were single fractures, multiple fractures, wounds/cuts/infections, and amputations (in order of incidence). The most common mechanism was the foot slipping off the footplate during wheelchair mobility.
CONCLUSIONS: We observed inherent weaknesses in the MAUDE database reporting process and a concerning level of reporting bias. Although there were limited reports of injuries related to ILED on the footplate during wheelchair mobility, the injuries reported were significant. More standardized reporting of the mechanism and impact of these injuries is needed to better inform wheelchair design, prescription, and patient/family education.
Language: en |