MAUDE Adverse Event Report: CONVATEC LTD AQUACEL AG BURN; DRESSING, WOUND, DRUG

Model Number	403786
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 3 of 4.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: 1000317571, third party manufacturing site: 3007648359.
Event or Problem Description
The product specialist, reporting on behalf of known hospital, noted that upon opening the box, the customer discovered that four pieces had incomplete seals.This caused the items to be exposed to outside air, rendering them unsterilized.Out of the five pieces in the box, only one piece remained completely sealed.The edges of the package envelope were still straight and evenly aligned, indicating no hand cutting by the customer.Additionally, the size of the envelope was consistent with that of a completely intact one.This was the second time the customer detected a similar issue from the same batch but a different box.The photographs are also available depicting the issue.
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: investigation findings: root cause: human error ¿ sealing process not correctly followed during packing.¿ staff involved: two operators (no longer with the company), so no retraining applied.¿ supplier impact: not involved.¿ scope: no further batches or items deemed affected.Actions & resolution: ¿ affected pouches were quarantined and segregated.¿ no rework or concession issued ¿ items were rejected.¿ preventative step included a prior email reminder to supervisors in march, advising operators to pay closer attention.This investigation will be closed.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: 1000317571.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: AQUACEL AG BURN
• Common Device Name: DRESSING, WOUND, DRUG
• 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 ; 3365424679
• MDR Report Key: 22179170
• Report Number: 1000317571-2025-00057
• Device Sequence Number: 12902163
• Product Code: FRO
• UDI-Device Identifier: 00768455124121
• UDI-Public: 00768455124121
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K090254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: 403786
• Device Lot Number: WO034144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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