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

Model Number	422358
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign matter-like contaminant hair inside dressing.The product was not used by the patient.The photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Device 1 of 2 e1: complainant last name: (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: 1049092 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.Complaint was received from japan reporting foreign matter (hair) within two sequential primary packs of aquacel foam pro 15x15cm (system application product (sap) 1724192, lot 4m03618).The lot was manufactured on 17-dec-2024 and sterilized under certificate wo (b)(4) (sterigenics).Batch size: (b)(4) secondary packs (b)(4) primary).Seven photographs were provided and reviewed in accordance with work instruction (wi).The expected product and lot numbers were confirmed.The images showed medium-length hair across two sequential dressings (unit numbers (b)(4).The hair appears cut in two, consistent with contamination occurring on the circle line during placement of dressings onto the primary pack paper web, prior to marrying of film/paper and sealing/cutting of the sachet.No physical sample was returned.The complaint is therefore confirmed.A full batch record review was completed for lot 4m03618.All in-process checks, stat sample inspections, and final release verifications were documented as acceptable.No deviations, rework, or non-conformances were identified.No packaging or equipment faults were recorded.Trend review confirmed no other complaints of hair contamination for this lot, and no similar complaints for this product across other lots.Historical investigations confirmed that while current personal protective equipment (ppe) is compliant for controlled environment use, it may still allow occasional loose hairs to transfer from garments or operator handling.Supplier material transfer cannot be entirely ruled out.Good manufacturing practice (gmp) audits are performed regularly to verify compliance with gowning and environmental controls.Risk assessment: the defect was classified as regulatory (foreign matter inside sterile barrier).According to process instruction, the acceptable quality level (aql) for primary pack contamination is 0.40 (accept 1, reject 2 at n=125).At manufacture, lot 4m03618 met inspection acceptance criteria.Post-distribution, two affected units have been reported from (b)(4) distributed units.This equates to a rate below the 0.40 aql threshold across the full batch size and does not constitute an aql excursion.The presence of hair in two sequential dressings would not have been visible to operators during online manual inspection due to the line speed and sachet configuration; the hair was trapped on the web path prior to sealing and not visible once the film was in place.This explains why the contamination was not identified during in-process visual checks.With only two units affected, the batch remains within specification and acceptable quality limits.The issue is considered isolated, with no systemic recurrence identified.In accordance with work instruction (wi), no corrective action / preventive actions (capa) is required.The complaint will be monitored through routine trending and 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 FOAM PRO
• 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 27409 ; 3365424679
• MDR Report Key: 22662796
• Report Number: 1000317571-2025-00080
• Device Sequence Number: 19752232
• Product Code: NAC
• UDI-Device Identifier: 00768455157334
• UDI-Public: 00768455157334
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 422358
• Device Lot Number: 4M03618
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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