HYBRESIS
Received Oct 6, 2010 · Event occurred Sep 7, 2010
Report 1721293-2010-00017 · MDR key 1864777
Device
Product problems
- Insufficient Device Problem Information
Patient
34 YR
- Caustic/Chemical Burns
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A RESEARCH PROJECT TO DETERMINE IF CALCIFIC DEPOSITS IN THE PATELLAR TENDON OF THE KNEE CAN BE REDUCED USING A REGIMEN OF 5% ACETIC ACID DELIVERED BY HYBRESIS IONTOPHORESIS. AFTER 142 MINUTES OF DELIVERY VIA THE HYBRESIS PROTOCOL, NO NEGATIVE EFFECTS WERE NOTED UNDER THE PLACEBO PAD, BUT A SECOND DEGREE CHEMICAL BURN THE SIZE OF THE DRUG RESERVOIR WAS NOTED. THE PT WAS SEEN BY A SURGEON AND NOTED THE BURN TO BE THIRD DEGREE, SURGERY WAS PERFORMED TO REMOVE THE DEAD SKIN.
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT NUMBER IS UNK. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. THE UNIVERSITY AND OTHER STATE AGENCIES WERE LOOKING INTO THE INJURY AND THE BOTTLE THAT SUPPOSEDLY CONTAINED 5% ACETIC ACID. THE INVESTIGATION SHOWED THAT THE BOTTLE LABELED AS 5% ACETIC ACID ACTUALLY CONTAINED A MUCH HIGHER CONCENTRATION. THUS, THEY HYBRESIS IONTOPHORESIS PATCH WAS NOT THE CAUSE OF THE BURN.