Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Please note: three (3) issues associated with this product; therefore a separate fda form 3500a has been generated to address the other two (2) cases reported under patient identifier# (b)(6).Reported to the fda on july 18, 2014.Note: the actual date of event ( is unknown, so the date used was the date convatec became aware.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.
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