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

Model Number	409270
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
Initial reporter: (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.
Event or Problem Description
It was reported eight wafers were made off center, so much that the end user could not use it.No photo was provided.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
No samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.In addition, a complaint search for lot 8a03528 and malfunction code ost-pmc1.18 skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only) was carried out and as a result, no additional complaint was found; therefore, no trend is observed.As per complaint manufacturing investigation procedure wi-0359, version 4.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed.Lot 8a03528 was manufactured on 01/19/2018, form fill and seal #1 line, with a total of (b)(4) units.Complaint investigator id 6055 performed a batch record review on 09/28/2020, description steem syn moldable cvx33/45mm(1x10pk)nl 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 1165362 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.

• 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: 8008696
• Report Number: 9618003-2018-02540
• Device Sequence Number: 1472692
• Product Code: EXE
• UDI-Device Identifier: 00768455185719
• UDI-Public: 00768455185719
• 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,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: 01/18/2023
• Device Model Number: 409270
• Device Lot Number: 8A03528
• 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: 10/02/2018
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/10/2023
• 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: Female