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

Model Number 422357

Device Problem Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

It was reported by distributor that the patient had used the product for some time which was unclear since when.The dressing change interval was unknown.It was stated that the last two dressings were more difficult to remove and partially stuck to the wound bed which on changes were painful.There was pain in the wound bed during removal which disappeared shortly after removal.There was no bleeding.It was unknown if wound was secreting less.No photograph was available at this time.

Manufacturer Narrative

Device 2 of 2 (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was completed and no discrepancies were found.Aq foam pro 10x10cm 1x10pk ster eur was manufactured under systems applications and products in data processing (sap) code 1727477 and manufacturing lot number 3a02371 on 21 jan 2023.Lot # 3a02371 was sterilized under work order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All of the results were within specification and products were released.No photographs were received for this issue, so it was not possible to evaluate in accordance with work instruction (wi).It was not possible to obtain any images or any further information from the complaint.As no images were received, it was not possible to confirm the complaint.No samples were available.The clinical team were asked for comment on the issue, but the complaint record did not include much information relating to the patient.The complaint had been received from a pharmacy, which in turn does not have access to patient details.The complaint record identified the patient had been using the product for some time, but it was unclear since when.The dressing change interval was not known, so it was not possible to identify how long the dressing had been used for, but the patent identified that the last 2 dressing changes were painful due to it being more difficult to remove and partially stuck to the wound bed.Pain was experienced but disappeared shortly after dressing removal.No bleeding was identified, but it was also unknown if the wound was producing less exudate.No further information was available, so not all circumstances of the dressing use were known.It is possible that the wound was dry and that use of saline could have helped the dressing become less stuck, but the exudate levels were not known.If the wound had been exuding less, then it is possible that the dressing has been able to adhere to the wound as it is not moist enough.As very little information is available for the dressing usage or the wound condition, it is not possible to identify any nonconformance.As no images or samples were available to confirm the complaint, and not enough information was known about the condition of the patient¿s wound, it is not possible to fully investigate the issue.The batch record of the product did not identify any discrepancies, so as no issue could be identified from the complaint or the batch record, no further investigation is possible.This issue will be monitored through the post market product monitoring review process 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.

• Brand Name: AQUACEL FOAM
• Type of Device: 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: 17883862
• MDR Text Key: 325071254
• Report Number: 1000317571-2023-00284
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455157327
• UDI-Public: 00768455157327
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 422357
• Device Lot Number: 3A02371
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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