SONICATOR PLUS ME940
Received Apr 15, 2013
Report 2013558-2013-00002 · MDR key 3074702
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Erythema
- Burn, Thermal
Narrative
Description of Event or Problem
AFTER RECEIVING UNIT FOR REVIEW, I WAS TOLD THAT THIS WAS NOT THE FIRST TIME OR ONLY TREATMENT (AS WAS STATED INITIALLY) - IT WAS THE FOURTH TREATMENT IN DC MODE - THE ONLY CHANGE WAS THE LOCATION OF THE PADS DURING THE TREATMENT.
Additional Manufacturer Narrative
AS OF DATE OF THIS REPORT, DEVICE HAS NOT BEEN RETURNED TO METTLER FOR EVALUATION. IT IS BEING HELD IN THEIR BIO-MED DEPARTMENT. PER (B)(4) (RISK MGMT), THEY ARE HOLDING THE DEVICE FOR AT LEAST ANOTHER WEEK IN ORDER TO LET THE THERAPIST MAKE CONTACT WITH THE PATIENT.
Description of Event or Problem
PER (B(6) (FACILITY MGR (B)(6) MEDICAL CENTER), A FEMALE PATIENT, COLLEGE AGE, ALLEGEDLY WAS BURNT ON HER ANKLE DURING A DC STIM TREATMENT AT 5 MA. I THEN SPOKE TO (B)(6) (PHYSICAL THERAPIST) THAT CONDUCTED THE TREATMENT AND WAS TOLD THE PATIENT HAD RECEIVED VARIOUS TREATMENTS PRIOR TO THE ALLEGED INCIDENT. MS. (B(6) ADMINISTERED EMS (ELECTRICAL MUSCLE STIM) TREATMENTS WITH NO PROBLEMS BUT FELT EVEN BY INCREASING THE MA THAT THE TREATMENT IN EMS WASN'T PRODUCING THE RESULTS. SO, SHE THOUGHT THAT BY USING DC (DIRECT CURRENT), IT WOULD GIVE HER BETTER CONTRACTIONS WHILE LOWERING THE MA - UPON FIRST AND ONLY TREATMENT USING DC THE ALLEGED INCIDENT HAPPENED. THERE WAS NO BURN AT THE TIME OF TREATMENT - ONLY SKIN REDNESS - HOWEVER, 30 MINUTES AFTER PATIENT ARRIVED AT HOME, SHE NOTIFIED PT OF BURN ON ANKLE (UNDER PAD OF BLACK ELECTRODE CABLE ONLY). PATIENT MADE CONTACT WITH PRIMARY PHYSICIAN FOR WOUND CARE AFTER ALLEGED INCIDENT.