MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACCORDION FLANGE; PROTECTOR, OSTOMY

Model Number	421033
Medical Device Problem Codes	Material Disintegration (1177); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 1 of 2.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 that for 2 out of 10 wafers from 1 market unit, when the end user attempted to mold, the center of the moldable material was shredding and coming apart.This occurred prior to use, but she used them anyway as she had no other wafers on hand.There was no harm reported.A photograph depicting the issue was received from the complainant.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Returned sample evaluation: photograph associated with this case were received in which the reported defect can be observed.No unused return sample was received for evaluation.Conclusion summary of the related event: based on the results of the preliminary investigation, the batch record review was performed and no discrepancies were found.In addition, the failure modes reported could not be replicated.Furthermore, through the process investigation it was concluded that the reported issues can be associated to the mixing process.The root cause investigation tw# (b)(4) was generated in which the causes and actions identified are directly related with the problems reported by the customers.For all the explanation above, a root cause investigation (rci) is not necessary.Should additional information become available, a follow-up report will be submitted.Fda registration number, reporting site: 1049092, manufacturing site: 9618003.

• Brand Name: ACCORDION FLANGE
• 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: 10850184
• Report Number: 9618003-2020-15256
• Device Sequence Number: 3489413
• Product Code: EXE
• UDI-Device Identifier: 00768455133697
• UDI-Public: 00768455133697
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: 04/30/2025
• Device Model Number: 421033
• Device Lot Number: 0D03923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female