MAUDE Adverse Event Report: FUELMEFOOT COPPER COMPRESSION SOCK; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Full thickness (Third Degree) Burn (2696); Blister (4537)

Event Date 05/01/2020

Event Type  Injury  

Event Description

Patient was wearing a compression sock containing copper.He is diabetic and has neuropathy which starts just below his knee, so he does not have good sensation of the skin just below the knee all the way to his toes.He was sitting in the sun for several hours.Later on he noticed blistering of the right leg when he removed the sock.He ultimately had third degree burns and required medical treatment with many visits to a wound clinic.Fda safety report id# (b)(4).

• Brand Name: FUELMEFOOT COPPER COMPRESSION SOCK
• Type of Device: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
• MDR Report Key: 12136148
• MDR Text Key: 260510417
• Report Number: MW5102347
• Device Sequence Number: 1
• Product Code: DWL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR