Background information: sunrise medical, as a practice, reports all reports of end-user pressure sores that break through the skin (stage 2 and above) as a "serious injury" because this level of injury typically requires intervention to ensure they do not progress.Discussion: in an incident reported to have occurred almost one year before sunrise medical was notified, end-user reports that tilt function on his wheelchair was not working properly.Sunrise medical has not had the opportunity to evaluate the subject wheelchair to determine what, if anything, may have interfered with the tilt function.It was further reported that the end-user developed "sores on his rear." the initial reporter did not disclose the stage of the pressure sore.Pressure sores are a frequent condition in long-term wheelchair users due to their preexisting conditions.Without additional information about the injury, sunrise medical is unable to reach a determination as to possible root cause without speculation.Pressure sores, if not treated correctly may progress to a serious injury.Therefore, it is out of an abundance of caution that sunrise medical has elected to file this report because it has a practice of filing reports for stage 2 pressure sores, it is unclear what stage of pressure sore was involved here, and it is unclear whether or not the subject device may have caused or contributed to a serious injury or if any malfunction has occurred that could cause or contribute to a serious injury.Conclusion: due to the allegation of the "tilt function not working properly", there is a possibility that the device did not perform as intended; accordingly, this is classified as a malfunction.Due to this end-user alleging "sores on his rear" (i.E., pressure sores), there is a possibility that this end-user may have needed medical intervention; accordingly, this is classified as a potential for serious injury.Therefore, this report is being filed as sunrise medical understands this meets the criteria defined in 21 cfr 803.50(a) for manufacturer reporting requirements.
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End user reports that tilt function on his wheelchair was not working properly and he developed "sores on his rear." there is no report regarding the severity of the pressure sore(s), but pressure sores, without treatment, can progress to a serious injury and, therefore, this report is being filed out of an abundance of caution.
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