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

Model Number	411659
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 14 of 20.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
On (b)(6) 2020, the end user inspected 20 unused wafers from 2 market units with the same lot number and confirmed that the starter hole was off centered in all of the moldable products.No photo is available at this time.
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 are no photographs associated with this case no unused returned sample was received.Conclusion summary of the related event: a complaint search performed in database by manufacturing date for the ¿starter hole off center or misaligned¿ failure mode for ats#1 and ats#2 manufacturing lines shows a decreasing trend from jun 2019 to date (cut off september 30, 2020).Based on the preliminary investigation, the most probable cause for the cases related to manufacturing process in the ats#1 and ats#2 manufacturing lines is related to machine condition.As part of the nonconformance report (ncr) actions were taken for this failure mode, which were the main factors for the reduction in the quantity of complaints per month.In addition, the root cause investigations (rci¿s) and were carried out and actions were taken for the off-center failure mode in the convex two (2) piece (ostomy) and convex two (2) piece (wct) bulks manufacturing lines.Furthermore, a nonconformance search was performed in database from 2018 to september 30, 2020, for the ¿starter hole off center or misaligned¿ failure mode for ats#1 and ats#2 manufacturing lines and as a result, no events related to this malfunction were found.Moreover, the following quality and manufacturing controls are currently in place in the ats#1 & ats#2, according to the product instructions and test methods, which contribute directly to the detection activities: ¿ manufacturing process instructions (pi21-130 - ats1 assembly and packaging / pi21-122 - ast2 assembly and packaging) 1.Visual inspection to completed product 100% of units 2.Testing and inspection log ¿ dimensional verification and visual inspection looking for collar concentricity 6 samples at the beginning of the batch and each 1 hour ¿ quality test methods (tm-017 ¿ visual nonconformities laminated adhesive products / tm-014 ¿ pouch nonconformities) a quality notification was given to the quality and manufacturing personnel of the ats#1, ats#2, convex two (2) piece (ostomy) and convex two (2) piece (wct) manufacturing lines, to make them aware of the new complaints received for this failure mode (refer to attachment #3 and attachment #5 of this ncr).For everything explained above, no additional actions are required.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: 10012689
• Report Number: 9618003-2020-10688
• Device Sequence Number: 19395127
• Product Code: EXE
• UDI-Device Identifier: 00768455186990
• UDI-Public: 00768455186990
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 06/08/2024
• Device Model Number: 411659
• Device Lot Number: 9F04878
• 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: 04/21/2020
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 11/15/2023
• 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: Unknown