MAUDE Adverse Event Report: CONVATEC LIMITED UNNA FLEX ELASTIC UNNA BOOT; BANDAGE, ELASTIC

Model Number 650941

Device Problems Leak/Splash (1354); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2016

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

It was reported the bandage leaks which contributed to stains on the primary package."the package was closed upon receipt but probably had a hole." the product was not used on a patient.

Manufacturer Narrative

Additional information that was obtained confirmed the following: a return sample is not available for return.The primary complaint is that the packaging is leaking.It cannot be confirmed that the primary package stain is as a result of the reported leakage or that there was a hole seen in the primary packaging.Additionally, the bandage is packaged as a moist/wet bandage, not a dry bandage.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on october 11, 2016.

Manufacturer Narrative

A non-conformance report (ncr) has been opened to investigate leaking unna-flex unna boot 4" x 10 yards elastic bandages, icc code 65094.A preliminary investigation was performed and two units were identified as leaking from lot# 1600030302, which remained at the distribution center.All other product identified as leaking from complaints were discarded.Lot # 1600030302 was 100% inspected and only the two (2) units mentioned in this ncr appear to have leaked.No negative affect on product, safety, or patient risk as any leaking substance is not harmful to touch.The third party manufacturer has been notified of this issue.This complaint will remain open until the ncr is complete.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on june 28, 2017.

• Brand Name: UNNA FLEX ELASTIC UNNA BOOT
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5832951
• MDR Text Key: 52066059
• Report Number: 1000317571-2016-00063
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 650941
• Device Lot Number: 1600030262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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