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

Model Number 65091

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Manufacturer Narrative

The report submitted on 09/30/2015, with the patient identifier (b)(6) had the incorrect manufacturer report number 3007648359-2015-30112 listed.The correct manufacturers report number should have been 1000317571-2015-30112.(b)(4).

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.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): CONVATEC LIMITED; first ave; deeside industrial park; deeside, flintshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; global qarac headquarters; 7900 triad center drive, #400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5311281
• MDR Text Key: 161600028
• Report Number: 1000317571-2015-30112
• 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
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• 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: 65091
• Device Lot Number: 1600030167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• 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