MalfunctionLPQ
SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM
Received Apr 15, 1996
Report MW5000019 · MDR key 34176
Device
Generic name
Fracture Healing System
Manufacturer
Exogen, Inc.Product problems
- Reaction
Patient
NO INFO
- Pain
- Arthralgia
Narrative
Description of Event or Problem
A POSSIBLE SENSITIVITY REACTION WHICH WAS FIRST REPORTED TO CO ON 2/26/96. THE PT COMPLAINED OF AN ACHING PAIN IN THE WRIST DURING TREATMENT. HE DISCONTINUED USE OF THE DEVICE AFTER TWO TREATMENTS. THE DEVICE WAS RETURNED TO CO ON 3/18/96 FOR A COMPLETE CHECK. THE SYSTEM WAS FOUND TO BE OPERATING WITHIN THE PRESCRIBED PARAMETERS. A REPORT WAS SENT TO HIS PHYSICIAN.