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); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant street address: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: there were photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Batch record revision results: lot 3l00585, order (b)(4), material 1257758, was manufactured on 20/nov/2023 in the surgical cover dressing (scd) packaging manufacturing line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 21/feb/2025 and it was confirmed that the applicable procedures were followed, the components for assembly were correct as per bill of materials (bom) and the equipment settings were the applicable ones.The batch record review supports that there were no discrepancies related to the issue reported.The defect reported by the customer could occur during the following process: extrusion, lamination & cutting process performed in the elc #10 line: the subassembly lots 3l00589 and 3k02184 were manufactured in the elc #10 line.The complaints investigator performed a batch record review on 21/feb/2025 and it was confirmed that the applicable procedures were followed, the materials were correct as per bill of materials (bom) and the equipment settings were the applicable ones.The batch record review supports that there were no discrepancies related to the issue reported.Historical complaints review: on 21/feb/2025, complaints investigator ran a query in database in order to verify if additional complaints were reported for the lot 3l00585 for the malfunction ¿foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc)¿ and no additional complaints was identified.Historical nonconformance review: on 21/feb/2025, complaints investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction ¿foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc)¿ for the lot number 3l00585, 3l00589, 3k02184 and as result, no nonconformance / corrective action / preventive actions (capa) (s) for this malfunction were generated during the manufacturing process of the referenced lots.Defect rate analysis: there have only been 01 defective part confirmed to date from a lot size of (b)(4) products.This represents a defect rate of (b)(4), which is well within an appropriate acceptable quality level (aql) for this defect which should (b)(4) based on our standard operating procedure (sop).In addition, all of the in-process testing on this lot did not find a single defective unit, which confirms that the lot is unlikely to breach an acceptable quality level (aql) of (b)(4).To date, it is well within our accepted acceptable quality level (aql) for this type of failure mode or defect.Conclusions: as photographs were available for this complaint issue, they were evaluated and as a result, the reported malfunction for the observed product was confirmed, however, after performing the defect rate analysis for this issue, it was observed that the quantity of reportedly affected products is within the appropriate acceptable quality level (aql) for this defect.The review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction ¿foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc).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: 9618003.
Event or Problem Description
The hospital notified the distributor that the dressing had turned an abnormal black color.Upon opening a brand-new product, it was observed that the color was different from what was expected.The product was not used by the patient.The photographs depicting the issue were received from the complainant.

• 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: 21591517
• Report Number: 9618003-2025-00999
• Device Sequence Number: 8220035
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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: 412010
• Device Lot Number: 3L00585
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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