MAUDE Adverse Event Report: CONVATEC INC. NATURA DURAHESIVE MOLDABLE CONVEX SKIN BARRIER; PROTECTOR, OSTOMY

Model Number 404594

Device Problem Device Operates Differently Than Expected (2913)

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 additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

End user reported that the wafer was difficult to remove on the second or third day but, did not want to leave it on for an extra day.End user does not want to use an alternate product.No patient complications were reported as a result of this event.

• Brand Name: NATURA DURAHESIVE MOLDABLE CONVEX SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5048596
• MDR Text Key: 24769781
• Report Number: 1049092-2015-00498
• 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: Other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 404594
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR