MAUDE Adverse Event Report: CONVATEC LTD AQUACEL AG+ RIBBON WSF; DRESSING, WOUND, DRUG

Model Number	413570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the product broke even before using, (several times), and after using it broke again and was left behind in the wound.They were unable to remove it." per additional information received, the dressing was changed twice a day.Photos depicting the reported complaint issue were provided by the complainant.
Additional Manufacturer Narrative
Device 1 of 2.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.
Additional Manufacturer Narrative
Aquacel ag+ wsf 1x45cm (1x5pk)ster eur was manufactured under system application product (sap) code 1708336 and manufacturing lot number 3f00342 on 02 june 2023.Lot # 3f00342 was sterilized under reference id 2173-38396a and released on review of results of sterilization provided by sterilization company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3f00342.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue so could be evaluated in accordance with work instruction (wi).The photos shows the expected product and complaint issue, where a broken dressing is shown following removal from a wound.The lot number of the product is not shown in the images.Unused complaint samples were requested on 03 october 2023, and were received 16th october 2023.Upon receipt of the complaint samples, several dressings from the packs received were checked for tensile strength.A dry tensile test was completed on the samples, to confirm all dressings met the specification.The tensile testing was completed against specification and test method, with the specification 6n/cm being exceeded with all tested dressings.This confirms all dressings tested have met specification.As no inconsistencies or discrepancies were identified within the batch record, no nonconformance is identified.The dressings have been found to meet specification.The image provided with the complaint has raised some questions with the clinical team.The complainant has been asked the dressing change frequency, as the dressing does not look fully gelled and therefore may be more difficult to remove.The dressing change frequency was identified as twice per day, which was identified as frequent.European customer support were asked why the dressing changes were so frequent, and it was identified from the healthcare professional that this was due to exudate levels, although it would not be ecs advice, but that they do what is considered right at the time.If high exudate levels were not maintained throughout the twice daily dressing changes, it is likely that the dressing has not gelled properly and has become stuck and separated in the wound.The dressing has a tensile specification of 6n/cm, so this force could easily be exceeded when pulling the dressing from the wound if it remains fairly dry.It was confirmed that the dressings had not been cut prior to use, but it is possible for forces above the specification to have been exerted on the dressing when removing it.As no nonconformance was identified, the dressing is thought to be within specification and no further investigation is required.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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
To date no additional patient or event details have been received.

• Brand Name: AQUACEL AG+ RIBBON WSF
• Common Device Name: DRESSING, WOUND, DRUG
• 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: 17913696
• Report Number: 1000317571-2023-00288
• Device Sequence Number: 12613758
• Product Code: FRO
• UDI-Device Identifier: 00768455132058
• UDI-Public: 00768455132058
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 06/01/2025
• Device Model Number: 413570
• Device Lot Number: 3F00342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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: Unknown