| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-04-01 | 0 | 1. O |
Patient 1
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO ISSUES. THE FREQUENCY AND SEVERITY OF THE EVENT IS WITHIN THE EXPECTED LIMITS. WE COULD NOT DETERMINE THE CAUSE OF THE EVENT.
Patient 1
IT WAS REPORTED TO EMPI ON (B)(6) 2011 THAT A PATIENT SUFFERED A BURN UNDER THE NEGATIVE SIDE OF THE HYBRESIS ELECTRODE PATCH. ON (B)(6) 2011, IT WAS REPORTED THAT THE BURN WAS THIRD DEGREE. ON (B)(6) 2011, THE PATIENT WAS BEING TREATED FOR MEDIAL AND LATERAL EPICONDYLITIS. BEFORE THE HYBRESIS TREATMENT, THE PATIENT RECEIVED MFR FOLLOWED BY ULTRASOUND TO THE FOREARM. FOR THE HYBRESIS TREATMENT, THE COMPOUND USED WAS DEXAMETHASONE, THE CONCENTRATION WAS 4.0 MG/ML, AND THE AMOUNT OF DEXAMETHASONE USED WAS 2.0 ML. THE TREATMENT MODE USED WAS HYBRESIS. THE PATIENT REPORTED PAIN DURING THE 3-MINUTE INITIAL TREATMENT USING THE CONTROLLER. THE PATCH WAS WORN FOR AN ADDITIONAL 2 HOURS. IT WAS REPORTED THAT THIS WAS THE PATIENT'S TWELFTH HYBRESIS TREATMENT. THE PATIENT RETURNED THAT AFTERNOON TO THE CLINIC WITH A 1 CM DIAMETER BURN. THE AREA WAS BLACK, CHARRED AND NO BLISTERS. THE CLINICIAN REPORTED THAT THE BURN WAS UNDER THE NEGATIVE PAD. TO THE CLINICIAN'S KNOWLEDGE THE PATIENT DID NOT RECEIVE MEDICAL ATTENTION.