HYBRESIS
Received Oct 6, 2010 · Event occurred Dec 18, 2009
Report 1721293-2010-00009 · MDR key 1867762
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A PT WAS BURNED DURING A HYBRESIS TREATMENT. THE TREATMENT WAS ON THE FOOT OF THE PT AND WAS BURNED IN A CIRCULAR PATTERN EXACTLY IN SIZE TO THE BATTERIES. PT DID NOT SEEK MEDICAL ATTENTION.
Additional Manufacturer Narrative
THE ACTUAL SUSPECT PATCH WAS NOT RETURNED TO EMPI FOR EVAL. TWO UNOPENED BOXES AND TWO UNOPENED PACKAGES WERE RETURNED OF THE SAME LOT NUMBER. A SAMPLE WAS TAKEN FROM THE RETURNED PRODUCT AND PASSED ALL SPECS. THE BATTERIES USED ON THE PATCH AT THE TIME OF TREATMENT WERE RETURNED ALSO AND TESTED. THE BATTERIES TESTED TO SPECS AND PASSED. THIS REPORT IS BEING SUBMITTED BECAUSE EMPI HAS RECEIVED A SIMILAR COMPLAINT THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.