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

Model Number	404593
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 9618003-2024-02349 / device 1 of 11.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
The end user reported that plastic was exposed at edge under mass.Also, it was stated that some mass appeared to be off centered.The product was not used.The photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H3: device evaluated by manufacturer? has been selected as yes h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary.Photograph, video and/or physical sample evaluation: there were photographs associated with this case and in these, the reported defect could not be identified.In addition, samples have been received and it has not been possible to identify the reported defect.Batch record revision results: lot 3f04554 was manufactured on 23/jun/2023, in convex 2 pc line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 08/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)1156501 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction process instruction (pi).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 nonconformance review: on 08/jan/2025, complaint investigator ran a query in database in order to verify the complaints reported for 3f04554 lot related to the malfunction ¿inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer)¿ and as result no additional nonconformance were identified during this search as per work instructions (wi).Historical complaints review: on 08/jan/2025, complaints investigator ran a query in database in order to verify the complaints reported for the lot 3f04554 corresponding to the malfunction ¿inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer)¿ defect and as result no additional complaints were identified during this search as per work instructions (wi).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: skin barrier must be checked by visual inspection.This test method (tm) describes the visual examination of laminated adhesives for the purpose of assessing both cosmetic and functional nonconformities.Test methods (tm) ¿visual nonconformities - laminated adhesive products¿ frequency: hourly, sample quantity: 5 samples, acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 10 defective parts confirmed to date from a lot size (b)(4) products.This represents a defect rate of only (b)(4) which is well within an appropriate acceptable quality level (aql) for this defect which should be 0.25% based on our standard operating procedure (sop).In addition, all of the in-process testing on this lot did not find a single defective skin barrier, which confirms that the lot is unlikely to breach an acceptable quality level (aql) of 0.25.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) for this type of failure mode or defect.Summary of investigation: photographs have been received from the customer; however, the defect reported could not be identified.In addition, samples have been received, and it has not been possible to identify the reported defect.Therefore, it was not possible to conduct an investigation for the reported issue.A review of the batch record 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.A review of historical complaints and nonconformance was performed, and no additional issues were identified.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or 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.
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: 19658083
• Report Number: 9618003-2024-02349
• Device Sequence Number: 6914441
• Product Code: EXE
• UDI-Device Identifier: 00768455126675
• UDI-Public: 00768455126675
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/07/2024

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: 404593
• Device Lot Number: 3F04554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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