MAUDE Adverse Event Report: CONVATEC INC 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
Event or Problem Description
It was reported by the product specialist on behalf of the hospital that when opening the box, the end user found that two pieces (2 pcs) of dressings had incomplete seals, which had caused the items to be exposed to outside air and making them non-sterile.It was further clarified that there had been no tearing mark to open the envelope, the edge of the package had remained straight and evenly aligned, and the size had been the same as the seal dressing.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Mdr./ device 2 of 2.E1: complainant country: thailand name of hospital: (b)(6) hospital.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.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: d8: was this device ever service by a third party? d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H3: device evaluated by manufacturer? has been selected as yes h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause.H11: investigation summary.Investigation findings: the affected pouches were returned to brightwake, and an investigation confirmed they had not been sealed properly.The error was not caught during packing, and two employees responsible for this stage no longer work at the company.Human error was determined as the root cause, with the process not correctly followed.No similar previous occurrences were found, and no additional risk to other batches was identified.Actions taken: the affected items were quarantined at the factory.A reminder email was sent on march 12, 2025, to all supervisors to reinforce process diligence.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 INC; 211 american avenue; greensboro NC 27409
• 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: 21291718
• Report Number: 1000317571-2025-00008
• Device Sequence Number: 13072799
• Product Code: FRO
• UDI-Device Identifier: 00768455124121
• UDI-Public: 00768455124121
• Combination Product (Y/N): N
• 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): 01/09/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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