MAUDE Adverse Event Report: BRIGHTWAKE LIMITED UNNA-FLEX UNNA BOOT 4"X10YD; BANDAGE, ELASTIC

Model Number 650941

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

It was reported that the middle the bandage was frayed.

• Brand Name: UNNA-FLEX UNNA BOOT 4"X10YD
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): BRIGHTWAKE LIMITED; sidingw road, lowmoor business; nottinghamshire, NG17 8EA; UK NG17 8EA
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5113898
• MDR Text Key: 27260264
• Report Number: 3007648359-2015-30112
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/05/2013
• Device Model Number: 650941
• Device Lot Number: 1600030167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2011
• 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