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

Model Number	422356
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	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the complainant had noticed a drawing on the product.It had not been opened or used.The package had been recently received at the sample warehouse.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
E1: complainant street address: (b)(6), complainant city: (b)(6) complainant state: (b)(6) complainant postal code: (b)(6) complainant phone: (b)(6), complainant country: switzerland.Name of affiliation: (b)(6).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: (b)(4).Manufacturing site: 1000317571.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.A batch record review was completed and no discrepancies were found.Aq foam pro heel19.8x14cm 1x10 ster eur was manufactured under system application product (sap) code 1727476 and lot number 4l03650 manufactured on 21 november 2024.Lot # 4l03650 was sterilized under order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 4l03650.This was the only complaint for the affected lot registered within database.2 photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the expected lot number, product and complaint issue.The mark on the product appears to be a dark hair that was stuck on the external pink polyurethane (pu) of the dressing pad at the edge beside the adhesive border.Based upon the dressing size, the hair was estimated as being 25mm (millimetre) -30mm (millimetre) long.An non-conformance (nc) / corrective action / preventive actions (capa) was not raised for this issue as it was identified to be below acceptable quality level (aqls).The acceptable quality level (aqls) from process instruction (pi) identify contamination as (b)(4), with an accept 5 and reject 6 based upon a sample of 500 secondary packs and batch size of (b)(4) secondary packs.As only 5 packs remain in distribution center (dcs), it was likely over (b)(4) packs have been exhausted.A single primary pack has been reported for foreign matter, so this issue remains below acceptable quality level (aqls) and no corrective action / preventive actions (capa) new was necessary at this time.The hair appears to be fairly short and it was possible that the hair could have originated from an exposed part of the required controlled environment coverings, e.G.Eyelashes, eyebrows.Previous complaints have warranted an non-conformance (nc) and investigation (tw(b)(4) and tw(b)(4) to identify how a hair could have been sealed into the primary sachet.It was confirmed current personal protective equipment's (ppes) kit was suitable for use in the controlled environment, but it does allow movement which may allow loose hairs to transfer onto garments and in turn may transfer onto material and products while working in the controlled environment.Hair may also be transferred from supplier materials which cannot be ruled out as a possible cause.Good manufacturing practices (gmp) audits are regularly conducted to ensure all good manufacturing practices (gmp) activities are being followed.This single hair would also not have been visible at the time the dressings were manually inspected as the dressing pad faces the inside of the primary sachet and was therefore not visible.As this was the only affected dressing, the issue does not exceed acceptable quality level (aqls), no further investigation was necessary.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: 9618003.
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; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 21706027
• Report Number: 1000317571-2025-00024
• Device Sequence Number: 10071895
• Product Code: NAC
• UDI-Device Identifier: 00768455157310
• UDI-Public: 00768455157310
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: 422356
• Device Lot Number: 4L03650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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