Aquacel/ aquacel ag surgical cover dressing.Dressing, wound, hydrophilic.(b)(6).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.The complainant was unable to provide the model number, lot number or product sizing information.Therefore, we are unable to determine the specific manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.(b)(4).
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