BACK SUPPORT BELT
Received Mar 22, 2013 · Event occurred Mar 11, 2013
Report MW5029430 · MDR key 3020651
Device
Product problems
- Fluid/Blood Leak
- Device Emits Odor
- Fumes or Vapors
Patient
68 YR
- Nausea
Narrative
Description of Event or Problem
PURCHASED BACK SUPPORT BELT FROM CONSUMER SHOPPING THROUGH (B)(6). OPENED THE PACKAGE OF THE FIRST BACK SUPPORT BELT, AN ODOR EMITTED FROM IT AND A WATER SUBSTANCE WAS LEAKING FROM IT. CONTACTED THE SELLER AND THEY AGREED TO SEND HIM ANOTHER ONE. PT RECEIVED THE SECOND BACK SUPPORT BELT ON (B)(6) 2013 AND A NOTICEABLE ODOR EMITTED FROM IT AS WELL. THE TOXIC FUME FILLED THE ROOM WHICH MADE PT NAUSEOUS. THERE IS A LABEL WARNING ON THE DEVICE INDICATING IT CAN CAUSE CANCER, BIRTH DEFECTS AND REPRODUCTIVE HARM. PT IS CONCERNED THAT THE DEVICE IS TOXIC WHICH CAN CAUSE SERIOUS PROBLEMS TO CONSUMERS.