Brand nme: aquacel/ aquacel ag surgical cover dressing.Common device name: dressing, wound, hydrophilic.Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional information has been requested, however to date no additional information has been received.The lot number was not provided.Therefore, we are unable to determine the specific manufacturing site.Two (2) potential manufacturing site numbers are listed below.Should additional information become available, a follow-up report will be submitted.(b)(4).
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