COMPRESSIONZ COMPRESSION SOCKS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-11 for COMPRESSIONZ COMPRESSION SOCKS manufactured by Compressionz.

Event Text Entries

[82611212] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071552
MDR Report Key6791600
Date Received2017-08-11
Date of Event2017-07-31
Date Added to Maude2017-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPRESSIONZ COMPRESSION SOCKS
Generic NameCOMPRESSIONZ COMPRESSION SOCKS
Product CodeFQL
Date Received2017-08-11
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOMPRESSIONZ


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-11

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