MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL AG SURGICAL; DRESSING, WOUND, DRUG

Model Number	412010
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
The distributor reported that, the dressing package was unstitched/shredded and was found during undressing.The product was not used.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Device 4 of 5.E1: complainant information: 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: 9618003.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Emdr retraction: the initial emdr with manufacturing report number (9618003-2025-01110), was submitted on 27-mar-2025.However, as per additional information received that this issue is not related to opened package.The cause of this defect is that the release paper separates from the dressing, and when the dressing is taken out, the release paper remains in the packaging.Now, this case has been determined to be non-reportable.Hence, this emdr is being submitted to retract the initial emdr.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.
Additional Manufacturer Narrative
Emdr retraction: the initial emdr with manufacturing report number (9618003-2025-01110), was submitted on 27-mar-2025.However, as per additional information received that this issue is not related to opened package.The cause of this defect is that the release paper separates from the dressing, and when the dressing is taken out, the release paper remains in the packaging.Now, this case has been determined to be non-reportable.Hence, this emdr is being submitted to retract the initial emdr.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 AG SURGICAL
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• 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: 21705823
• Report Number: 9618003-2025-01110
• Device Sequence Number: 19997501
• Product Code: FRO
• UDI-Device Identifier: 00768455124282
• UDI-Public: 00768455124282
• Combination Product (Y/N): N
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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 Expiration Date: 09/01/2026
• Device Model Number: 412010
• Device Lot Number: 3J01135
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/09/2025; 04/09/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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