BODYMED 1.25 IN ROUND CARBON ELECTRODE

Description of Event or Problem

ON (B)(6) 2013, CUSTOMER SERVICE TOOK A CALL IN WHICH A CHIROPRACTOR'S OFFICE REPORTED A PT WAS BURNED BY ONE OF OUR ELECTRODES ((B)(4)). THEY REPORTED THAT THE PT WAS BURNED ON HER RIGHT LEG ON (B)(6) 2013. THIS PT IS DIABETIC. UPON REMOVAL OF ELECTRODE, THEY NOTICED A SMALL BURN THAT THE DOCTOR FELT WAS CAUSED BY A "HOT SPOT." THEY DID NOT HAVE THE USED ELECTRODE. THEY REPORTED THAT THEY HAVE NOT HEARD FROM THIS PT UNTIL RECENTLY WHEN THE PT CALLED TO SAY THAT SHE WAS IN THE HOSPITAL FOR THE BURN AND THE HOSPITAL HAD RELEASED HER TO A WOUND CARE CLINIC FOR THE TREATMENT OF THE BURN. FOLLOW UP ON (B)(6) 2013, THE DOCTOR STATED - "THEY HAVE TREATED THIS PT BEFORE WITHOUT ANY INCIDENT. AFTER THIS TREATMENT ((B)(6) 2013), AND UPON REMOVAL OF THE ELECTRODE, THEY NOTICED A SMALL RED SPOT (LESS THAN 1 CM) THEY TREATED IT WITH BETADINE AND NEOSPORIN IN THE OFFICE, TOLD THE PT HOW TO TREAT AT HOME, AND SENT HER ON HER WAY." PT THEN CALLED BACK A COUPLE OF DAYS AFTER TREATMENT AND SAID THE SPOT TURNED INTO A BLISTER AND AGAIN THEY TOLD HER HOW TO TREAT THE BLISTER. THE DOCTOR DID NOT HEAR ANYTHING FROM THE PT UNTIL A FEW DAYS AGO WHEN HE FOUND OUT THAT THE BLISTER WAS INFECTED AND SHE WAS BEING TREATED BY A WOUND CARE/BURN SPECIALIST. FOLLOW UP ON (B)(6) 2013, THE DOCTOR STATED HE MET WITH THE PT ON WEDNESDAY, (B)(6) 2013 AND ALSO STATED THAT HE WANTED TO TAKE A PICTURE, BUT DID NOT FEEL IT WAS APPROPRIATE FOR THAT MEETING. DOCTOR ALSO STATED THAT THE PT WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS AND THEN TRANSFERRED TO A WOUND CARE SPECIALIST IN WHICH THE PT WAS RECEIVING TREATMENT. FOLLOW UP ON (B)(6) 2013, THE DOCTOR REPORTED THAT HE DID NOT HAVE ANY OF THE ELECTRODES TO SEND BACK. THE MACHINE THAT THEY USED WAS A GALVANIC STIMULATION UNIT (VECTOR GENESIS MODEL #2781; SERIAL NUMBER (B)(4)). HE SAID HE DID NOT KNOW FOR SURE IF THERE WERE OTHER ISSUES, IN ADDITION TO THE "BURN", THAT LEAD TO HER ADMISSION. HE WAS ASSUMING THAT THE PT WAS ADMITTED SPECIFICALLY FOR THE BURN AND WHEN ASKED ABOUT THE LENGTH OF STAY, HE SAID 2 DAYS BUT THAT WAS BASED ON PIECING TOGETHER THE CONVERSATIONS BETWEEN HIM AND THE PT. THE DOCTOR STATED THAT THE PT HAD TO CANCEL HER APPOINTMENT WITH THE NEUROLOGIST BECAUSE OF HER BEING TREATED BY THE WOUND SPECIALIST.