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

Model Number	413179
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 end user reported that the wafer hole was off centered prior to use in ninety wafers from nine market unit boxes.The end user did visually inspect the wafers.She further reported that some openings were off-centered more than others.The end user further added that she had a major abdominal surgery and was in the hospital for a month and had a very slow recovery and ended up back in the hospital for a couple of days and had many of doctors appointments.Photograph depicting the issue was received from the complainant.
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 imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.Batch record review: lot 1j04787 was manufactured on 10/06/2021, convex 2 pc (wct) manufacturing line, with a total of (b)(4).Complaint investigator performed a batch record review on 06/30/2022 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct.Sap material 1161268 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Complaint data analysis: on 06/30/2022, complaint investigator performed a search of complaints into database system for lot number 1j04787.As a result, a total of two complaints were found reported and one related to the same malfunction code of this investigation.Returned sample evaluation: two photographs associated with this case were received and no unused return sample was expected.Conclusion summary of the related event: the purpose of this investigation was to determine the root cause associated investigation wafer disc decentralized, for lots manufactured in convex 2 pc awc facilities.The risk level based on the individual risk acceptability criteria and risk evaluation above is medium, meaning that these risks may be accepted but further risk control measures shall be considered if they are feasible and will reduce the risk further.Risks judged moderate are considered acceptable based on an acceptable risk-benefit profile and must be assessed for the need for post market surveillance.After understanding the process, a brainstorming tool was used to determine all the possible causes of the problem; the cause & effect diagram was used and as a result there were found seven (7) potential causes identified.One (1) of them were discarded, and six (6) were confirmed and retained as root/probable cause for the failure.Based on the investigation findings, the root causes for wafer decentralized were identified as manpower, method and machine, see the table below for details: probable root cause: manpower: 1.Procedure pi (convex 2pc wafer sub assembly machine 2) not followed by manufacturing personnel while placing the mass on loading pins.2.Manufacturing inspections failed to be executed as applicable.Machine: 3.Pistons defective.4.Base thread of k tool loading pin defective.5.Electro-valve damaged.Method: 6.Manufacturing inspections failed to be executed as applicable.The correction action and preventive action plan was generated to cover the probable causes, taking appropriate actions and measure its effectiveness.The investigation associated with related event was approved and complete.No additional action was 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: 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: 13964484
• Report Number: 9618003-2022-00422
• Device Sequence Number: 4163510
• Product Code: EXE
• UDI-Device Identifier: 00768455124497
• UDI-Public: 00768455124497
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/10/2022

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: 10/05/2026
• Device Model Number: 413179
• Device Lot Number: 1J04787
• 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): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 07/26/2022
• Date Device Manufactured: 10/06/2021
• 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