MAUDE Adverse Event Report: COMPRESSIONZ COMPRESSIONZ COMPRESSION SOCKS

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 07/31/2017

Event Type  No Answer Provided  

Event Description

I purchased several pairs of compression socks through (b)(6) made by (b)(6).The socks are great and i really like them, so i have ordered 15 pairs.I loved these socks until today that is! i walked through a welding shop and a spark struck my right sock and it burst into flames! the "fuzz" of the material ignited violently over the entire sock.The flames died out quickly only scorching my leg hair and causing a slight surface burn.These socks have been washed several times and were clean.Not only would i say these socks are not flame retardant, i would say they are flammable! i realize the fire only involved the fuzzy surface, and once it burned off, the flames quickly dissipated.However this could easily spread to other combustible materials.Please examine this product to ensure it meets the required safety standards.Incident location: (b)(6).Product category: clothing and accessories.Retailer: (b)(6).Purchase date: (b)(6) 2017.I still have the product in my possession: yes.The product was damaged before the incident: no.The product was modified before the incident: no.Document number: (b)(4).Report number: (b)(4).

• Brand Name: COMPRESSIONZ COMPRESSION SOCKS
• Type of Device: COMPRESSIONZ COMPRESSION SOCKS
• Manufacturer (Section D): COMPRESSIONZ
• MDR Report Key: 6791600
• MDR Text Key: 82611212
• Report Number: MW5071552
• Device Sequence Number: 1
• Product Code: FQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR