Based on available information, this event is deemed a reportable malfunction.It was further reported that the "hospital is concerned with infection".Additional event info was provided via email on (b)(4) 2014 informing that they replaced the device due to the continued issues with sleeve inflation and moisture build-up.No info was provided or reported that any infections had occurred to pt(s); they further informed that they cannot determine exact number of pt(s) involved and the product was used in the surgical intensive care unit.They went on the inform that it is unk how long the product was in use prior to the event occurring.Please note: issue occurred on five (5) separate cases.A separate 3500a form has been completed for the other (4) cases under pt identifier(s):# (b)(6).Mfr report(s):# 3007966929-2014-00017, 3007966929-2014-00021, 3007966929-2014-00023 and 3007966929-2014-00025 respectively.(report 2 of 5) no additional pt/ event details have been provided to date.Should additional info become available a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.Note: the actual date of event is unk, so the date used was the date convatec became aware.
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