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

Model Number	409268
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It is reported by the end user that five out of ten wafers had stoma openings off-center, causing a decreased wear time of one day.No harm reported.
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: lot 8b01409 was manufactured on 02/15/2018 in the line ffs #1, with a total of (b)(4) ea.Compliance engineer performed a batch record review on 11/18/2020, 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 1169247 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: there are no photographs associated with this case 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: machine: the investigative process concluded that all the machinery/ tooling items used in the manufacturing process complied when compared against and procedure instruction (pi) pi31-087 ver.10.0 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) pi1-087 procedure was recently updated to version:9.0 to modify the (6qnf0049 and 6qnf0050) tooling and a new 6qnf0004 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.Actions were taken on corrective action / preventive actions (capa) plan.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: ESTEEM SYNERGY
• 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: 8537507
• Report Number: 9618003-2019-02620
• Device Sequence Number: 311964
• Product Code: EXE
• UDI-Device Identifier: 00768455185696
• UDI-Public: 00768455185696
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 02/14/2023
• Device Model Number: 409268
• Device Lot Number: 8B01409
• 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: 04/05/2019
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male