MAUDE Adverse Event Report: CONVATEC INC L3W0650 - AQUACEL FOAM; DRESSING,WOUND,HYDROPHILIC

Model Number	420680
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user reported that the wound dressing was used as secondary dressing.It was alleged that it caused allergy and irritation.However, as per photograph provided and clinical review, it was determined that the photo did not represent an allergic response.Instead, it showed what appeared to be tissue damage at the area of the dressing where the silicone meets the hydro fiber.There was redness and macerated tissue characteristics, as well as full thickness tissue damage as per the photograph provided.
Additional Manufacturer Narrative
(b)(6).(b)(4).Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: L3W0650 - AQUACEL FOAM
• Common Device Name: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 12923202
• Report Number: 1049092-2021-00660
• Device Sequence Number: 4958321
• Product Code: NAC
• UDI-Device Identifier: 00768455127115
• UDI-Public: 00768455127115
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/01/2024
• Device Model Number: 420680
• Device Lot Number: 1C04454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown