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

Model Number	411806
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that the central aperture of the skin barrier wafer was misaligned.The product was not used.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
E1: complainant country: china based on the available information, this event is deemed to be a reportable malfunction.Batch record review: lot 4b04675 was manufactured on 22/feb/2024, in ats #2 line, with a total of (b)(4) market units (mkus).The complaints engineer performed a batch record review on 23/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) 1224651 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 was a photograph associated with this case, and in this, the reported defect can be seen.No unused return sample was expected.Historical complaints review: on 23/feb/2026, complaints engineer ran a query in database in order to verify the complaints reported for the 4b04675 lot for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ defect and no additional complaints were identified.Historical nonconformance review: on 23/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 ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ defect for the lot number 4b04675 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) ¿package seal integrity nonconformities - method 8¿ frequency: hourly sample quantity: 1 market unit acceptance criteria: accept = 0 | reject = 1.Dimensional inspection: film release liner: the film must remain intact along the length of the wafer without any cuts in the center hole.The film release tab must be free and not be trapped under the adhesive disk.Frequency: hourly sample quantity: 3 samples per cavity acceptance criteria: accept = 0 | reject = 1.Collar concentricity: support ring concentric within 2.0 mm to the collar through the cut.Concentricity meter: (45mm flange: 3dka0001-01) frequency: hourly sample quantity: 6 samples of disc collar machine acceptance criteria: accept = 0 | reject = 1.- adhesive disc alignment: the disc must not contact the srp adhesive disc id collar and must be concentric within 2.0mm.Frequency: hourly sample quantity: 3 samples per cavity acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there has been only 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 0.25% based on our 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 0.25.Importantly 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.

• 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: 24466016
• Report Number: 9618003-2026-00435
• Device Sequence Number: 18095786
• Product Code: EXE
• UDI-Device Identifier: 00768455187065
• UDI-Public: 00768455187065
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: Health Professional
• Device Model Number: 411806
• Device Lot Number: 4B04675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• 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