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

Model Number	411804
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that ten wafer starter holes were off centered.The product was not used by patient.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Device 3 of 10.E1: complainant country: china.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: 1049092.Manufacturing site: 9618003.
Event or Problem Description
To date no additional patient or event details have been received.
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.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 5g04398 was manufactured on 18/jul/2025, in ats #2 line, with a total of (b)(4) market units (mkus).The senior complaints engineer performed a batch record review on 05/nov/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.Delta crusader line supplies the adhesive discs to ats #2.For this reason, a batch record review of the subassembly lot was performed.Lot 5g04432 was manufactured on 18/jul/2025 with a total of (b)(4) units.The senior complaints engineer performed a batch record review on 05/nov/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.A nonconformance associated to the lot number 5g04398 for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ was identified.Through the nonconformance database an investigation was performed, and it was determined that the assignable cause was an incorrect adjustment of the cutters in the manufacturing machine.Immediate corrective actions were taken to restore the machine settings, and a retraining session was provided to the involved personnel as per procedure process instruction (pi).A review of machine maintenance records confirmed that the equipment was in good condition before and after the event, as evidenced by the preventive maintenance inspections.After discovering the condition, ats 2 manufacturing personnel reinspected all related units and disposed of those found nonconforming.No additional defective products were detected during the reinspection process.Historical complaints review: on 05/nov/2025, senior complaints engineer ran a query in database in order to verify the complaints reported for different customers, specifically for the lot number 5g04398 for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ and as results, no additional complaints were found.Defect rate analysis: there have been 10 defective parts confirmed to date from a lot size of 38,000 products.This represents a defect rate of 0.0263% which was well within an appropriate acceptable quality level (aql) which should be 0.25% based on the standard operating procedure (sop).In addition, all the in-process testing on this lot did not find a single defective market unit, which confirms that the lot was unlikely to breach an acceptable quality level (aql) of 2.5 this issue certainly appears to be an isolated incident, but more importantly to date, it was well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: during the manufacturing process, a nonconformity was identified related to a decentralized center hole within the adhesive disc.The investigation determined that the assignable cause was an incorrect adjustment of the cutters in the manufacturing machine.Immediate corrective actions were taken to restore the machine settings, and a retraining session was provided to the involved personnel as per procedure process instruction (pi).A review of machine maintenance records confirmed that the equipment was in good condition before and after the event, as evidenced by the preventive maintenance inspections.After discovering the condition, ats #2 manufacturing personnel reinspected all related units and disposed of those found nonconforming.No additional defective products were detected during the reinspection process.The defect rate associated with this incident was found to be within the established acceptable quality level (aql) limits, indicating that the process remains under statistical control.Furthermore, no additional complaints or adverse events related to this condition have been received since.Based on the isolated nature of the issue, the verified equipment condition, and the effective immediate actions taken, no further action was required.Consequently, the complaint can be closed.The implemented retraining and continued monitoring under the standard preventive maintenance and in-process inspection program are sufficient to ensure ongoing process control and compliance.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: 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: 23461749
• Report Number: 9618003-2025-02862
• Device Sequence Number: 18413355
• Product Code: EXE
• UDI-Device Identifier: 00768455187041
• UDI-Public: 768455187041
• 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,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: 411804
• Device Lot Number: 5G04398
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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