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

Model Number	420637
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).H6: d17 appropriate code not available is selected under imdrf cause conclusion code since the issue was not related to manufacturing process and primary pack damage may have been caused by the delivery staff but has most likely occurred outside of convatec control during the distribution of the product.Based on the available information, this event is deemed to be a reportable malfunction.Aquacel foam n/adh 15x20(1x5) nai was manufactured under system application product (sap) code 1704004 and manufacturing lot number 2h00759 on 09 august 2022.Lot number 2h00759 was sterilised under work order (b)(4) and released on review of results of sterilisation provided by sterilisation company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2h00759.This is the only complaint for the affected lot registered within database.One photograph was received for this issue and have been evaluated in accordance with work instruction (wi).The photograph confirmed the expected product, lot, and the complaint issue, where a single primary package is shown to have an incision in a vertical direction through the printed label on the back of the primary sachet.No damage can be seen to the dressing itself.As the cut in the primary sachet appears to also show evidence of damage to the locally-applied language label on the sachet, it is most likely that the cut in the sachet had occurred after the local labelling has been added, and therefore not within the manufacturing process.As the sachet damage is ruled out from being caused by the manufacturing process, the issue was escalated to the distribution quality team.It was identified from the distributor¿s investigations for the issue that the primary pack damage may have been caused by the delivery staff but has most likely occurred outside of convatec control during the distribution of the product.The investigation has been approved and is complete.No additional action is required, and this complaint will be closed.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 end user to retailer that the primary package was damaged.The product was not used.A photograph depicting the issue was received from the complainant.

• 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: 17369439
• Report Number: 1000317571-2023-00165
• Device Sequence Number: 6978511
• Product Code: NAC
• UDI-Device Identifier: 00768455123865
• UDI-Public: 00768455123865
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

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: Lay User/Patient
• Device Model Number: 420637
• Device Lot Number: 2H00759
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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