MAUDE Adverse Event Report: ACCORDION FLANGE; PROTECTOR, OSTOMY

Model Number 421035

Device Problems Material Separation (1562); Delamination (2904)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

The end user reported that the wafer around the stoma appears to separate in layers.He stated that the durahesive moldable base layer stays adhered to his skin and then the middle layer begins to peel back which requires him to change the wafer.

Event Description

To date no additional patient or event details have been received.

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 6k01701 and malfunction code for inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer) was carried out and as a result, no additional complaint was found; therefore, no trend is observed.As per complaint manufacturing investigation procedure work instructions (wi), it is not required to open a nonconformance report (ncr) for type of complaints which were not confirmed.Lot 6k01701 was manufactured on 26 december 2016, form fill and seal #1 line, with a total of (b)(4).Complaint investigator performed a batch record review on 09/28/2020, description natura wfr moldable cvx 13/45mm (1x10)us to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct.System application product (sap) material identification (b)(4) and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.No additional event detail information has been provided to date.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
• Type of Device: PROTECTOR, OSTOMY
• MDR Report Key: 7307084
• MDR Text Key: 101573436
• Report Number: 9618003-2018-00048
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2021
• Device Model Number: 421035
• Device Lot Number: 6K01701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR