BIOSTIM

Additional Manufacturer Narrative

DEVICE HAS BEEN REQUESTED FOR RETURN. THE DEVICE HAS NOT RETURNED FOR INVESTIGATION THEREFORE NO INVESTIGATION CAN BE PERFORMED. IF THE DEVICE RETURNS AN INVESTIGATION WILL BE PERFORMED AT THAT TIME. A REVIEW OF THE DHR WAS PERFORMED - ALL 60 UNITS FROM THE WORK ORDER PASSED FINAL INSPECTION.

Description of Event or Problem

PATIENT REPORTED HAVING A REACTION TO THE UNIT CAUSING BURNS ON THE RIGHT LEG. PATEINT STATES IT STARTED THE FIRST DAY OF TREATMENT BUT THE UNIT DID NOT GET HOT, HE JUST HAD A REACTION. PATIENT DISCONTINUED USE. NO FURTHER DETAILS WERE REPORTED.