DURA-STICK II SELF-ADHESIVE ELECTRODES
Received Oct 3, 2011 · Event occurred Aug 1, 2011
Report 1022819-2011-00011 · MDR key 2275494
Product problems
- Accessory Incompatible
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
THE PT CLAIMED THEY WERE BURNED WHEN USING DJO SUPPLIED ELECTRODES WITH A NON DJO ELECTROSTIMULATOR. THE SERIOUSNESS OF THE BURN WAS NOT PROVIDED AND NO MEDICAL INTERVENTION WAS REQUIRED. END USER WAS USING DJO DURA-STICK II ELECTRODES WITH A NON DJO ELECTROSTIMULATOR DEVICE. AS THIS DEVICE WAS NOT RETURNED TO DJO THE FUNCTIONAL CONDITION IS UNK. UNUSED ELECTRODES WERE RETURNED TO DJO AND EVALUATED AND FOUND TO BE FULLY OPERATIONAL. AS DJO CANNOT CONCLUSIVELY DETERMINE IF THE CAUSE OF THE REPORTED EVENT IS DUE TO THE NON DJO ELECTROSTIMULATOR THIS EVENT IS BEING REPORTED.
Additional Manufacturer Narrative
ADD'L DATA: ACTUAL ELECTRODES USED DURING THE EVENT WERE NOT RETURNED FOR EVAL. UNUSED ELECTRODES FROM SAME PACKAGE WERE RETURNED AND EVALUATED WITH NO ISSUES FOUND. CORRECTED DATA: REPORT ORIGINALLY ISSUED AND SUBMITTED WITH INCOMPLETE MFR REPORT NUMBER 1022819-2011-00009. MFR REPORT NUMBER CORRECTED TO 1022819-2011-00011 AS SHOWN.