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

Model Number	413418
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Complainant country: canada.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: (b)(4).
Event or Problem Description
The end user reported that one of samples of the wafer had starter hole off centered.The end user also stated that wafer was mostly looked off centered starter hole, as there was much more material to roll back on one side than the other.The flange ring itself was in the middle of the appliance.The product was not used.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.C22 and d17 were selected under imdrf investigation findings and imdrf cause conclusions respectively because they are not adequately described by any other term for "an over the time fade on the criteria for the decentralization defects and the correct use of the tooling available on the line".Batch record review: lot 2l02923 was manufactured on 29/nov/2022, in ats #2 line, with a total of (b)(4) market units (mkus).Compliance engineer performed a batch record review on 29/mar/2023, 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 id 1703890 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: photo related to the reported problem is available for evaluation.Conclusion summary of the related event: during the event summary and impact evaluation of this nonconformance report (ncr), with the support of the triage team expertise, the most probable causes of the problem identified: after performing the root cause analysis, it was concluded that the non-conformance is related to an over the time fade on the criteria for the decentralization defects and the correct use of the tooling available on the line.The appropriate actions will be taken through the corrective and preventive actions (capas).The investigation associated with related event record has been approved and was complete.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.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 ; 3365424679
• MDR Report Key: 16425835
• Report Number: 9618003-2023-00236
• Device Sequence Number: 5798256
• Product Code: EXE
• UDI-Device Identifier: 00768455124008
• UDI-Public: 00768455124008
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 413418
• Device Lot Number: 2L02923
• 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): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• 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