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

Model Number	405478
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.Fda registration number: (b)(4).
Event or Problem Description
It was reported that "opening is off center".No harm reported, as product was not used on or by the patient.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.Returned sample evaluation: there is a photograph associated with this case and in this, the reported defect can be seen.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 action / preventive actions (capa) review board (monthly) and management review (biannual) for track and trending.No additional action is considered necessary for this record.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.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: 8167718
• Report Number: 9618003-2018-04083
• Device Sequence Number: 11199067
• Product Code: EXE
• UDI-Device Identifier: 00768455185443
• UDI-Public: 00768455185443
• 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: 02/21/2023
• Device Model Number: 405478
• Device Lot Number: 8B02103
• 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: 11/29/2018
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 12/15/2018
• Supplement Report FDA Received Date: 08/24/2023
• 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: Male