Based on the available information, this event is deemed to be a serious injury since the patient did seek medical treatment and received a prescription.It is reported that end-user cleanses skin with (b)(6) adhesive remover wipes then washes with (b)(6) and water then dries.In addition, end-user applies (b)(6) protective barrier wipes and allows to dry.Lastly, it is reported that end-user occasionally uses adapt powder.This case is related to patient identifier #: (b)(6), reported under manufacturer's report #: 1049092-2014-00149.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.
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The product associated with batch 3l01957 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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