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

Model Number 420680

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Tissue Breakdown (2681)

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 281661065
• Report Number: 1049092-2021-00660
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455127115
• UDI-Public: 00768455127115
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1