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

Model Number	125273
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 consumer reported that the precut opening in the skin barrier was far off-center, making it too close to the flange.Due to this defect, they were unable to apply the skin barriers properly.The issue was identified visually before any attempt to use the product.A total of thirty-eight skin barriers from four market units were affected.The consumer did not use the products and requested replacements, which were provided.No photo is available at this time.
Additional Manufacturer Narrative
Mdr (b)(4) / device 36 of 38.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, h11: investigation summary.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Batch record revision results: lot 5d00484 was manufactured on 02/apr/2025, in mlk line, with a total of (b)(4) market units (mkus).The senior complaints engineer performed a batch record review on 18/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.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 18/feb/2026, senior complaints engineer ran a query in database in order to verify the complaints reported for different customers, specifically for the lot number 5d00484 for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ and as results, no additional complaints were found.Historical nonconformance review: on 18/feb/2026, senior complaints engineer ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the lot number 5d00484 for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ and as results, no nonconformance / capa (s) for this malfunction were generated during the manufacturing process of the referenced lots.Current quality controls: based on the process instruction (pi), the following tests are performed in the manufacturing line, in order to identify this failure mode in our manufacturing process: test methods (tm) method 13 - concentricity test: sample quantity: 1 sample per rotary head / 12 samples per rotary.Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have been 38 defective parts confirmed to date from a lot size of (b)(4) products.This represents a defect rate of (b)(4) which was well within an appropriate acceptable quality level (aql) for leakage which should be (b)(4) as per process instruction (pi).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.Conclusion: no photographs for this complaint issue.Therefore, the defect could not be confirmed.The batch record has been reviewed, and all necessary tests during the manufacturing process and final product release have been completed and meet the requirements.It's important to note that the failure rate was 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: SUR-FIT 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: 23580358
• Report Number: 9618003-2025-02947
• Device Sequence Number: 21242904
• Product Code: EXE
• UDI-Device Identifier: 00768455125203
• UDI-Public: 768455125203
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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,Followup
• Report Date (Section B): 10/24/2025

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: 125273
• Device Lot Number: 5D00484
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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