MAUDE Adverse Event Report: ANDOVER HEALTHCARE, INC. POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE

Device Problem Device Emits Odor (1425)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

The wrap has a noxious odor, perhaps petroleum based? it was so strong, i had to remove the wrap and the clothes over it.My eyes stung there was no warning regarding use over non-intact skin or any other situation.Anything that smells that badly, must have to be detoxified by the liver or kidney.

• Brand Name: POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE
• Type of Device: POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE
• Manufacturer (Section D): ANDOVER HEALTHCARE, INC.
• MDR Report Key: 5700329
• MDR Text Key: 46685475
• Report Number: MW5062654
• Device Sequence Number: 1
• Product Code: FQM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: 1001 W (STAMPED ON PKG)
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 75