C-5 120V
Received Sep 23, 2008 · Event occurred Jul 8, 2008
Report 1022819-2008-00257 · MDR key 1171154
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
30 YR
- Erythema
- Burn, Thermal
Narrative
Description of Event or Problem
A MALE PT WAS RECEIVING COLD THERAPY FOR AN ACL REPAIR OF THE KNEE WHEN THE PT REC'D A COLD BURN TO THE SKIN SURFACE. THE CLINICIAN HAD NOTED PRIOR TO THE COLD TREATMENT APPLICATION THAT THE PAC WAS ABNORMALLY HARD. THE CLINICIAN APPLIED THE COLD PAC TO THE INJURY AREA. THE PT COMPLETED THE 20 MINUTE WITHOUT COMPLAINT. UPON REMOVAL OF THE TREATMENT PAC, THE CLINICIAN NOTED REDNESS OF THE SKIN IN THE AREA TREATMENT. THE PT DID NOT REQUIRE MEDICAL ATTENTION AS A RESULT OF THE REDNESS. THE PT CONTACTED THE CLINIC THREE DAYS LATER TO REPORT THAT THE SKIN DISCOLORATION HAD CLEARED UP.
Additional Manufacturer Narrative
THE DEVICE EVALUATION AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL.