InjuryMWZ
BRAVA
Received Jan 10, 2003 · Event occurred Dec 20, 2001
Report MW1027211 · MDR key 437279
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
26 YR
- Pain
- Rash
- Scarring
- Tingling
Narrative
Description of Event or Problem
INITIALLY USER WORE DEVICE FOR 10 HOURS A DAY AS RECOMMENDED BUT WHEN NO RESULTS WERE SEEN USER INCREASED THE DURATION FOR 14 HOURS A DAY AS INSTRUCTED BY MFR. THE DEVICE WAS USED FOR 7 MONTHS. USER EXPERIENCED PAIN, SORES, RASH, AND TINGLING.