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

Model Number	421041
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported that the nine moldable wafers from one market unit was stiffer and less pliable than usual, making it difficult to mold and keep in place.Although wear time remained unaffected (typically three to four days), she noticed a difference in the adhesive's feel.The stoma size and contours were unchanged, with the stoma at the product's maximum mold-to-fit size of forty-five millimeter (mm).There was no harm reported.She began using a new market unit and found its flexibility and moldability to be as expected.No photo or further information was available.
Additional Manufacturer Narrative
Device 6 of 9.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 4l00880 was manufactured on 05/nov/2024, in ffs #1 line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 23/jun/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) 1709736 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 23/jun/2025, complaints investigator ran a query in database in order to verify the complaints reported for the lot 4l00880 corresponding to the malfunction ¿skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿ defect and no additional complaints were identified during this search as per work instructions (wi).Historical nonconformance review: on 23/jun/2025, complaints investigator ran a query in database looking for any in process nonconformance / corrective and preventive actions (capa) (s) associated to the malfunction ¿skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿ defect for the lot number 4l00880 and as result, no nonconformance / capa (s) for this malfunction were generated during the manufacturing process of the referenced lot.Defect rate analysis: there have only been (b)(4) defective parts 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 (b)(4) 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 aql of (b)(4).This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: the batch records have been reviewed and all necessary tests during the manufacturing process and final product release have been completed and met the requirements.Additionally, a review of historical nonconformances showed no additional nonconformances.It's important to note that the failure rate is well within our accepted aql level for this type of defect.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: 22409720
• Report Number: 9618003-2025-02175
• Device Sequence Number: 20934584
• Product Code: EXE
• UDI-Device Identifier: 00768455133833
• UDI-Public: 00768455133833
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/20/2025

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: 421041
• Device Lot Number: 4L00880
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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 Age: 77 YR
• Patient Sex: Female