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

Model Number	125274
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 4 of 4.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.(b)(4).
Event or Problem Description
The end user checked her products and discovered wafers with off-centered starter holes.It was unknown whether the product was used.A photograph depicting the issue was received from the end user.
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: d4: unique identifier (udi).H6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Batch record review: the batch record review supports that there were no discrepancies related to the issue reported.This batch was manufactured following the applicable procedures, all machine and testing parameters were in accordance with the applicable procedures and specifications, the testing results were found satisfactory and no nonconformance related to the malfunction code in analysis was noted.The line clearance was executed ¿line clearance procedure and security check¿, the results were documented, and no issues were identified during the manufacturing process.The materials comply with the correct parameters, process instruction (pi), ds, mt, tm and the results are satisfactory.Photograph, video and/or physical sample evaluation: there is a photograph associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Executive summary of the non-conformance (nc): during the event summary and impact evaluation of this nonconformance report (ncr), with the support of the triage team expertise and the analysis of the applicable pfmeas, the most probable causes of the problem identified.An opportunity in the process was identified, since there is no functional or dimensional test implemented to inspect the concentricity of the disc in the mlk's.A visual test is currently being performed, but this defect may be visually imperceptible to the operator.A capa plan will be open to cover the preventive / corrective action resulted from this ncr.Furthermore, an ncr search conducted shows that no adverse trend was identified from january 2019 to november 2020 for this failure mode.For this reason, no additional investigation is needed.The investigation associated with related event has been approved and is 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.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
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 9749515
• Report Number: 9618003-2020-02463
• Device Sequence Number: 1568081
• Product Code: EXE
• UDI-Device Identifier: 00768455125210
• UDI-Public: 00768455125210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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

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 Expiration Date: 03/11/2024
• Device Model Number: 125274
• Device Lot Number: 9C00492
• 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: 02/06/2020
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female