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

Model Number	412012
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that a complaint was received from a hospital about a patient who had orthopedic surgery.The patient wore the company¿s known postoperative patch and no other products.When the customer replaced the patient with a new company¿s known dressing, he found that the patient's original patch had an obvious white area, which seemed to contain no silver (ag), and the function of absorbing exudate was not very good, so there was a reaction.Additionally clarified that the dressing was used up to three days and it was the first time to use it after surgery.The reaction was resolved and the patient does not have any other diagnoses.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
E1: (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: 9618003.
Additional Manufacturer Narrative
Emdr retraction: this emdr is being submitted to retract initial emdr with patient id (b)(6) with manufacturing report number (9618003-2024-02417), was submitted on 16-july-2024.However, investigation was completed on 06-sep-2024.Based on investigation results summary, the silver and absorbency tests were performed on all the batches.The results indicated that both the absorption and ag (silver) specifications were met, and the testing was passed.The dressings were also tested for silver, and they were found to be within specification.Special testing was carried out to check the dressings' reaction to potentially damaging chemicals and no discoloration was identified on the dressings following these tests.Therefore, the defect was not related to wound absorbency, rather it was just colour or texture of product not being uniform or consistent.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 DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 19748274
• Report Number: 9618003-2024-02417
• Device Sequence Number: 8874707
• Product Code: FRO
• UDI-Device Identifier: 00768455124275
• UDI-Public: 00768455124275
• Combination Product (Y/N): N
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (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): 06/21/2024

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: 01/01/2026
• Device Model Number: 412012
• Device Lot Number: 3A02447
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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