DONJOY AIRCAST CRYO/CUFF
Received Sep 23, 2011 · Event occurred Aug 26, 2011
Report 9616086-2011-00115 · MDR key 2265495
Device
Generic name
Cold Therapy Unit
Manufacturer
Dj Orthopedics De Mexico, S.a. De C.v.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
SERVICE OF SUMMONS AND COMPLAINT WAS MFR'S FIRST NOTICE OF THIS EVENT. PLAINTIFF'S COUNSEL CLAIMS IN THE COMPLAINT THAT THE PT SUFFERED UNDERLYING INJURY TO RIGHT SHOULDER. PRESCRIBED DONJOY AIRCAST CRYO/CUFF, TOGETHER WITH ITS ACCESSORIES, ON (B)(6) 2009 FOR TREATMENT OF UNDERLYING INJURY. USE OF DEVICE OCCURRED FROM (B)(6) 2009. SINCE ENDING USE OF DEVICE, PT DISCOVERED NON-FREEZING COLD INJURIES. DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE COMPANY HAS BEEN UNABLE TO CONFIRM THE MFR OF, OR INSPECT, THE DEVICE. BECAUSE THE MATTER IS IN LITIGATION, IT HAS BEEN TURNED OVER TO OUTSIDE COUNSEL FOR FURTHER INVESTIGATION.