MAUDE Adverse Event Report: CONVATEC, INC. NATURA® LOW PRESSURE DURAHESIVE® WAFER; PROTECTOR, OSTOMY

Model Number 421458

Device Problems Difficult to Remove (1528); Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.

Event Description

End user reports the mass melted and then hardened against the stoma and peristomal skin within about 36 hours, making it difficult to remove.

Manufacturer Narrative

A batch record review found no discrepancies related to the reported complaint.Process checks and quality checks were performed and yielded acceptable results.No additional action is required and this complaint will be closed.The issue will be monitored through the post market monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: NATURA® LOW PRESSURE DURAHESIVE® WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro, NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6010856
• MDR Text Key: 56806462
• Report Number: 1049092-2016-00424
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 421458
• Device Lot Number: 5M00054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR