HYBRESIS
Received Oct 17, 2011 · Event occurred Sep 19, 2011
Report 1721293-2011-00010 · MDR key 2298794
Device
Product problems
- Insufficient Device Problem Information
Patient
36 YR · Male
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED, AND IS IN THE EVALUATION PROCESS. WHEN THE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT USED THE HYBRESIS PATCH ON HIS LOWER BACK AND WAS BURNED. THE BURN WAS ON THE VERY EDGE OF THE PATCH ALONG THE ADHESIVE ON THE NEGATIVE SIDE OF THE PATCH. THE COMPOUND THAT WAS USED ON THE NEGATIVE SIDE OF THE PATCH WAS DICLOFENAC SODIUM. THE AMOUNT USED ON THE PATCH WAS 1.2ML AND THE CONCENTRATION WAS 1%. ON THE OPPOSITE SIDE OF THE PATCH WAS SALINE. THE PATCH WAS WORN FOR 2 HOURS IN HYBRESIS MODE. THE BURN WAS APPROXIMATELY 1/2 INCH IN DIAMETER AND LOOKED LIKE A CIGARETTE BURN. THE PATIENT EXPERIENCED STINGING DURING THE END OF THE TREATMENT. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT, AND SELF DIAGNOSED THE BURN AS A 3RD DEGREE.
Additional Manufacturer Narrative
THE RETURNED PATCH WAS MANUFACTURED CORRECTLY. THE SOLVENT APPEARED TO HAVE REACTED WITH THE AG/AGCL INK. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE SOLUTION APPLIED TO THE PATCH WAS NOT DESIGNED FOR IONTOPHORESIS USE. THE SOLUTION CONTAINED DICLOFENAC SODIUM, DIMETHYL SULFIDE, ALCOHOL, PROPYLENE GLYCOL, GLYCERIN, AND PURIFIED WATER. WE BELIEVE THAT THE APPLIED PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT.