OtherNYN
BIONICARE KNEE DEVICE
Received Aug 14, 2007 · Event occurred May 29, 2007
Report MW5003450 · MDR key 899870
Device
Generic name
Bionicare Knee Device
Manufacturer
Bionicare Medical Technologies, Inc.Model number
B1000Catalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
YR
- Swelling
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
THE PT USED THE DEVICE ON HER RIGHT LEG FOR A COUPLE OF HOURS AND EXPERIENCED SWELLING ABOVE THE RIGHT ANKLE. DUE TO THE PT'S DEFIBRILLATOR, SHE CONTACTED HER HEART DR WHO ADVISED HER TO DISCONTINUE USE.