HYBRESIS
Received Sep 17, 2010 · Event occurred Aug 18, 2010
Report 1721293-2010-00015 · MDR key 1841109
Device
Product problems
- Circuit Failure
- Sticking
- Device Dislodged or Dislocated
Patient
27 YR
- Burning Sensation
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE RETURNED FOR EVAL. A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT NUMBER IS UNK. A REVIEW OF THE MFG DOCUMENTATION COULD NOT BE PERFORMED. IF MORE INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PT WAS BURNED ON THE POSTERIOR SHOULDER AFTER BEING TREATED WITH A HYBRESIS ELECTRODE PATCH. THE BURN WAS APPROX 1CM ROUND AND CRATER LIKE, UNDER THE POSITIVE SIDE OF THE PATCH. THE COMPOUND USED WAS DEXAMETHASONE 1.5ML AND THE CONCENTRATION WAS 4MG/ML. THE COMPOUND WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH WITH SALINE ON THE POSITIVE SIDE OF THE PATCH. WHEN THE TREATMENT WAS FIRST STARTED, IT FELT OK. THE CONTROLLER BECAME SNAGGED ON THE SLEEVE OF THE PT AND PULLED HARD ENOUGH TO DISLODGE THE PATCH AND CREATED AN INCOMPLETE CIRCUIT. THE PATCH WAS RE-APPLIED AND CONTROLLER WAS RESTARTED AT WHICH POINT THE PT FELT A STRONG BURNING SENSATION. THE BURNING SENSATION LASTED ABOUT ONE MINUTE AND THEN WENT NUMB. THE TREATMENT WAS 3 MINUTES AND THE PATCH WAS WORN FOR 2 HOURS. PT WENT TO HER DR. THE NEXT DAY AND WAS TREATED WITH SILVADENE 1% TOPICAL CREAM TO USE TWICE A DAY.