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# (3): (b)(6) and (b)(6).Reported to the fda on july 18, 2014.The actual date of event (b3) 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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