MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; PROTECTOR, OSTOMY

Model Number	421033
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
Device 1 of 3 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 reported that multiple wafers had an off centered starter hole.He wore one and found two more in the box and also thought that his wife might have found more and those wafers were discarded.No photo was available at this time.
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 batch record review: lot 8j01834 was manufactured on 09/16/2018, line form fill and seal #1 with a total of 700 market units.The compliance engineer performed a batch record review on 12/31/2022, 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, under system application product (sap) material identification (id) 1709722 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: no photographs or videos associated with this case were received and no unused return sample was expected.Conclusion summary of the related event: based in the investigation findings, the root cause identified for the issue ¿centricity issues¿, reported under failure mode ¿skin barrier starter hole is defective (e.G., misalignment or off center), leakage may occur¿ is attributed to: 1)machine: the investigative process concluded that all the machinery/ tooling items used in the manufacturing process complied when compared against and procedure instruction (pi) specifications; as however, as part of this investigation it was identified that some size did not fit correctly in the disc assembly station produce the concentricity issues in the accordion line, nevertheless the procedure instruction (pi) was recently updated to modify the tooling and a new tooling was added to avoid problems of concentricity on the disks, due to these tooling shared disk size and at the time of assembly some size did not fit correctly in the welding process and caused concentricity issues during the manufacturing process.After this updated was performed the manufacturing line demonstrated to behave steadily after the correction.No issues were identified for material, measurement, method and environment investigations.Corrective and preventive actions identified will be taken through corrective/preventative action (capa) plan.This investigation is closed, and all corrective actions have been implemented.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.

• Brand Name: L3O0200 - 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: 15025715
• Report Number: 9618003-2022-00626
• Device Sequence Number: 6856973
• Product Code: EXE
• UDI-Device Identifier: 00768455133697
• UDI-Public: 00768455133697
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/21/2022

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: 09/15/2023
• Device Model Number: 421033
• Device Lot Number: 8J01834
• 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: 06/21/2022
• Supplement Date Received by Manufacturer: 12/31/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2018
• 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: Male