MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. DURAFIBER 5X5CM; DURAFIBER 5X5 CTN 10

Model Number 66800559

Device Problems Material Disintegration (1177); Difficult to Remove (1528)

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

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It was reported that it is difficult to remove the dressing.User states, during dressing change it was very difficult to remove the dressing because it disintegrates onto wound bed.

• Brand Name: DURAFIBER 5X5CM
• Type of Device: DURAFIBER 5X5 CTN 10
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle rd; hull HU3 2BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle rd; hull HU3 2BN; UK HU3 2BN
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau CH500-1 ; SZ CH5001
• MDR Report Key: 4887071
• MDR Text Key: 6064628
• Report Number: 8043484-2015-00121
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800559
• Device Catalogue Number: 6800559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other