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

Model Number	409269
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 was reported the starter hole was off center in four wafers.Photos depicting the reported complaint issue were provided by the complainant.
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 returned sample evaluation: there is a photograph associated with this case and in this, the reported defect can be observed.No unused returned sample was received.Conclusion summary of the related event: based on the analysis performed, even though there was an increasing tendency of complaints related to ¿off center starter hole¿ during 2018 and beginning of 2019, the updated data shows a positive tendency after the corrections executed to the automation tooling systems (ats#1 and ats#2) machines.Current quality and manufacturing controls have demonstrated to be adequate and effective since no non-conformances have been generated during the production process associated to the same failure from january 2018 to september 30, 2020.Also, this failure mode will continue to be monitored by the leadership during the corrective and preventive actions (capa) review board (monthly) and management review (biannual) for track and trending.No additional action is considered necessary for this record.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: 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: 8267675
• Report Number: 9618003-2019-00851
• Device Sequence Number: 13984848
• Product Code: EXE
• UDI-Device Identifier: 00768455185702
• UDI-Public: 00768455185702
• 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,Company Representative
• 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: Other
• Device Expiration Date: 05/29/2023
• Device Model Number: 409269
• Device Lot Number: 8E04546
• 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: 01/08/2019
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 08/08/2023
• 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: Unknown