InjuryIMF
ST100 THERMAL THERAPY SYSTEM
Received Aug 29, 1996 · Event occurred Aug 14, 1996
Report 40838 · MDR key 40838
Device
Generic name
Portable Cold Therapy Device
Manufacturer
Burke NeutechModel number
ST100Catalog number
*
Lot number
*
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
16 YR
- Ischemia
- Vasoconstriction
Narrative
Description of Event or Problem
"FROSTBITE" DUE TO CONTINUOUS COLD THERAPY TO HAND AND FOREARM POST-OP PLATE AND SCREW REMOVAL AFTER BONE HEALED FROM TRAUMATIC FRACTURE APPROX 18 MOS PRIOR. RETURNED TO HOSP POST-OP DAY 5 WITH SWOLLEN ARM AND HAND WITHOUT CIRCULATION OR SENSATION. REQUIRED EMERGENT SURGERY TO RESTORE CIRCULATION. HAD PORTABLE CONTINUOUS COLD THERAPY UNIT ON HAND FOR 48 HRS - 72 HRS POST-OP - IN HOME SETTING. QUESTION ADEQUATE PRODUCT LABELING AND PRINTED INSTRUCTIONS FOR HOME USE.