MAUDE Adverse Event Report: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING, WOUND, DRUG

Model Number	412011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Necrosis (1971); Skin Irritation (2076)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.(b)(6).The exact lot number could not be confirmed, as the hospital provided lot numbers for which they presently have available.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 patient/event details have been requested, but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
Event or Problem Description
The orthopedic physician reported that on (b)(6) 2017, he applied an aquacel ag surgical cover dressing post-operatively following left hip surgery.The physician indicated that after surgery he cleaned the wound with duraprep and loban.It was reported that on (b)(6) 2017, while checking on the surgical wound, the physician noted necrosis of the patient's skin where the skin was in contact with the dressing.It was further reported that there was blistering and bruises on the skin surrounding the wound.The necrotic skin was removed and the physician applied rofocine and fixomull.Photos were provided regarding the reported complaint issue.No further details have been provided.

• Brand Name: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 6704607
• Report Number: 1049092-2017-00037
• Device Sequence Number: 2013834
• Product Code: FRO
• UDI-Device Identifier: 00768455124299
• UDI-Public: 768455124299
• Combination Product (Y/N): N
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 412011
• Device Catalogue Number: 412011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR