MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number	187961
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
Device 2 of 16.E1: complainant street address: (b)(6).Complainant country: taiwan, province of china.Name of affiliation: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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 5a00145 was manufactured on 10/jan/2025, in doyen a line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 08/aug/2025, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material identification (id) 1704770 and manufacturing order (b)(4).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 discrepancy related to this issue were found within the documentation.Historical complaints review: on 08/aug/2025, complaints investigator ran a query in database in order to verify the complaints reported for the 5a00145 lot for the malfunction ¿foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc)¿ defect and only one (1) additional complaint was identified.Historical nonconformance review: on 08/aug/2025, complaint investigator ran a query in database looking for any in process non-conformance (nc)'s / 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 5a00145 and as result, no non-conformance (nc)'s / corrective action / preventive actions (capa) (s) for this malfunction were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction (pi), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test methods (tm)-002 " package seal integrity nonconformities".Method ¿ 7 (b)(4).Defect rate analysis: there have only been 32 defective parts confirmed to date from a lot size of (b)(4) products.This represents a defect rate of only (b)(4) which is well within an appropriate acceptable quality level (aql) for leakage which should be (b)(4) standard operating procedure (sop).In addition, all 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) this issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) for this type of failure mode or defect.Conclusions: a review of batch records was completed and showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancies related to this issue were found within the documentation.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 distributor reported that in an inbound inspection there were black spots inside the dressings.The photographs depicting the issue were received from the complainant.

• Brand Name: DUODERM
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• 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: 22858855
• Report Number: 9618003-2025-02275
• Device Sequence Number: 7622741
• Product Code: NAD
• UDI-Device Identifier: 00768455150878
• UDI-Public: 768455150878
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: 187961
• Device Lot Number: 5A00145
• 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: 07/30/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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