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

Model Number	187644
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 1 of 4.E1: (b)(6).Complainant country: taiwan, province of china.Based on the available information, this event is deemed to be a reportable malfunction.Batch record review: lot 4h01392 was manufactured on 08/23/2024, in bopack line, with a total of (b)(4) market units (mkus).The complaints engineer performed a batch record review on 26/feb/2026, 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) 1704758 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 was found within the documentation.The reported malfunction could be generated during the manufacturing process of the final line, therefore no further batch record review of the subassembly lots was required.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.Historical complaints review: on 26/feb/2026, complaints engineer ran a query in database in order to verify the complaints reported for the 4h01392 lot for the malfunction ¿primary pack (sterile products) is torn, ripped or contains holes.¿ defect and no additional complaints were identified.Historical nonconformance review: on 26/feb/2026, complaints engineer ran a query in database looking for any in process nonconformance / corrective and preventive actions (capa) (s) associated to the malfunction ¿primary pack (sterile products) is torn, ripped or contains holes.¿ defect for the lot number 4h01392 and as result, no nonconformance / corrective and 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) "sterile packaging inspection for nonconformities - visual attributes": frequency: every 30 minutes.Sample quantity: 1 market unit or nlt 5 blisters.Acceptance criteria: accept = 0| reject = 1.Defect rate analysis: there have been (b)(4) defective parts 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 be (b)(4) based on our test methods (tm).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) level for this type of failure mode or defect.Conclusion: 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 notified that outer box dented and damaged.However, as per photographs received, primary pack appeared damaged and torn.The product was not used.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: 24480997
• Report Number: 9618003-2026-00438
• Device Sequence Number: 16021735
• Product Code: NAD
• UDI-Device Identifier: 00768455174751
• UDI-Public: 00768455174751
• 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): 02/09/2026

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: 187644
• Device Lot Number: 4H01392
• 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: 02/09/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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