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

Model Number	420804
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant city: (b)(6).Complainant postal code: (b)(6).Complainant country: france.Name of affiliation: oxypharm.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.All in-process stat sample quality checks were satisfactory.Aquacel foam adh 8x8cm 1x10 eur was manufactured under system application product (sap) code 1707743 and manufacturing lot number 3b00195 on 06 feb 2023.Lot # 3b00195 was sterilized under work order 3242092 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 nonconformity was identified during the manufacturing process of lot 3b00195.This was the only complaint for the affected lot registered within database.No photographs were received for this issue, so it was not possible to evaluate in accordance with work instruction.No complaint samples were available so was not possible to confirm the complaint, nor complete testing on the dressings from the batch under complaint.As no samples or adequate images of the reported issue were received, it was not possible to open an nonconformance (nc) or corrective action / preventive actions (capa) to investigate this issue fully.Previous complaints for foreign matter insects have been received in the past, with an nc opened to investigate the issue.Without the samples and adequate photographs of the complaint samples for this complaint, it is not possible to complete an investigation for this issue specifically, but as the contamination/foreign matter appears was described as an insect, the previous nc investigation will be relevant.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.
Event or Problem Description
It was reported by a retailer to the company's representative that an insect was found between the dressing and the adhesive on (b)(6) 2023 product was not used.No photo was available at this time.

• 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: 17570568
• Report Number: 1000317571-2023-00178
• Device Sequence Number: 8765260
• Product Code: NAC
• UDI-Device Identifier: 00768455129089
• UDI-Public: 00768455129089
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: Other
• Device Model Number: 420804
• Device Lot Number: 3B00195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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