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

Model Number	187900
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)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that no box was received, just the dressings outside of the box and some of the blister packs were opened.He used some of the product anyway, but it adhered for only one day.No photograph was available at this time.
Additional Manufacturer Narrative
Device 2 of 20.Based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: · no photograph associated with this case was received.No return sample has been received for this complaint.Batch record revision results: lot 5e05997 was manufactured on 05/28/2025, in doyen a line, with a total of (b)(4) market units (mkus).The complaint engineer performed a batch record review on 04/mar/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) (b)(4)4 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.Historical complaints review: on 04/mar/2026, complaints engineer ran a query in database in order to verify the complaints reported for the 5e05997 lot for the malfunction "primary pack (sterile products) has incomplete or open seal or dressing or loose material is trapped in packaging" defect and only no additional complaint was identified.Historical nonconformance review: on 04/mar/2026, complaint 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) has incomplete or open seal, or dressing or loose material is trapped in packaging" for the lot number 5e05997 and as result, no nonconformance / capa (s) for this malfunction code 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) " package seal integrity nonconformities".Method - 7.· frequency: every 30 minutes.· sample quantity: 1 market unit o not less than (nlt) 5 chevrons.· acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have been 2 defective mkus confirmed to date from a lot size of (b)(4) mkus.This represents a defect rate of only (b)(4) which was well within an appropriate acceptable quality level (aql) (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 was unlikely to breach an aql of (b)(4) importantly, to date, it was well within our accepted aql level 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, and no additional complaints or in[?]process nonconformances were identified for the reported failure mode.Information received through customer communication indicates that the product was purchased through amazon and was delivered without secondary packaging and with some primary blister packs open.This presentation is inconsistent with convatec's standard manufacturing and distribution processes, where all units are released with intact primary packaging and enclosed within market[?]unit secondary packaging.The name of the amazon seller was requested in order to determine whether the issue may have occurred outside convatec control; however, the consumer did not provide the requested information.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.

• 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: 24557787
• Report Number: 9618003-2026-00522
• Device Sequence Number: 8828796
• Product Code: NAD
• UDI-Device Identifier: 00768455175048
• UDI-Public: 00768455175048
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: Lay User/Patient
• Device Model Number: 187900
• Device Lot Number: 5E05997
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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 Age: 60 YR
• Patient Sex: Male