SAFHS
Received Sep 27, 1995 · Event occurred Aug 8, 1995
Report MW5000010 · MDR key 28790
Device
Generic name
Fracture Healing System
Manufacturer
Exogen, Inc.Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
*
- Pain
Narrative
Description of Event or Problem
ON 8/8/95 A PT INFORMED THE CO SHE EXPERIENCED AN "ACHING" AT THE SITE OF TREATMENT. SHE HAD BEEN SHIPPED A UNIT ON 6/28/95. REPEATED ATTEMPTS WERE MADE TO CONTACT THE PT WITHOUT SUCCESS. ON 8/22/95 SHE CALLED TO STATE THAT SHE WAS RETURNING THE DEVICE ON HER DR'S INSTRUCTIONS DUE TO HER COMPLAINTS OF PAIN AT THE TREATMENT SITE. HER PHYSICIAN CONFIRMED THIS ON THE SAME DATE. UPON RECEIPT OF THE UNIT, IT WAS FOUND THAT THE PT HAD NOT BEEN COMPLIANT IN USING THE DEVICE AND HAD, IN FACT, ONLY USED IT FOR TWO DAYS IN AUGUST. THUS IT CANNOT BE DETERMINED IF THIS COMPLAINT WAS DEVICE-RELATED.