MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; PROTECTOR, OSTOMY

Model Number	125272
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that the sealed individual package of one pre-cut wafer had an opening that appeared larger and was off-centered.The product was not used.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
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: (b)(4).Manufacturing site: (b)(4).
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Photograph, video and/or physical sample evaluation: there was a photograph associated with this case; however, the reported defect cannot be seen.No return sample has been received for this complaint.Batch record revision results: lot 4c05860 was manufactured on 27/mar/2024, in mlk-3 line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 29/jan/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) 1051280 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 29/jan/2025, complaints investigator ran a query in database in order to verify the complaints reported for the 4c05860 lot for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ defect and no additional complaints were identified.Historical nonconformance review: on 29/jan/2025, complaints investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa)(s) associated to the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ defect for the lot number 4c05860 and as result, no nonconformance / 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)-001 "flange weld integrity - adhesive wafers"- method 13: frequency: hourly sample quantity: 6 samples per rotary acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 1 defective part 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 2.5% based on our process instruction.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 aql of 2.5.Importantly to date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: there was a photograph associated with this case, however the reported defect cannot be seen for evaluation in accordance with work instruction (wi).No samples were available for this complaint, and therefore it was not possible to confirm the complaint.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
To date no additional patient or event details have been received.

• Brand Name: NATURA
• Common Device Name: PROTECTOR, OSTOMY
• 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: 21216011
• Report Number: 9618003-2025-00363
• Device Sequence Number: 8639666
• Product Code: EXE
• UDI-Device Identifier: 00768455125197
• UDI-Public: 00768455125197
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: Lay User/Patient
• Device Model Number: 125272
• Device Lot Number: 4C05860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• 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