MAUDE Adverse Event Report: CONVATEC LTD AQUACEL FOAM; DRESSING,WOUND,HYDROPHILIC

Model Number	421559
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant city: (b)(6).Complainant country: united kingdom.Name of hospital: (b)(6) hospital.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 1049092.Manufacturing site: 1000317571.
Event or Problem Description
It was reported by the company's sales person, on (b)(6) 2023 that a nurse tried the company's known foam dressing as a sample / trial on healthy skin of right arm at a promotional stand meeting.It was on for about twenty-thirty seconds.The removal of dressing from skin was uncomfortable.The product was not replaced.A photograph was received from the complainant.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: AQUACEL FOAM
• Common Device Name: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 17227708
• Report Number: 1000317571-2023-00110
• Device Sequence Number: 20634870
• Product Code: NAC
• UDI-Device Identifier: 00768455142231
• UDI-Public: 00768455142231
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: 421559
• Device Catalogue Number: 421559
• Device Lot Number: 3B02432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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: Female