DONJOY ICEMAN MODEL 1100
Received Sep 23, 2011 · Event occurred Aug 26, 2011
Report 9616086-2011-00108 · MDR key 2265494
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Full thickness (Third Degree) Burn
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 LEFT SHOULDER. PRESCRIBED DONJOY ICEMAN MODEL 1100, TOGETHER WITH ITS ACCESSORIES, ON (B)(6), 2010 FOR TREATMENT OF UNDERLYING INJURY. USE OF DEVICE OCCURRED FROM (B)(6), 2010. 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.