MalfunctionEGJ
HYBRESIS
Received Nov 11, 2010 · Event occurred Oct 5, 2010
Report MW5018198 · MDR key 1900987
Device
Product problems
- Material Discolored
Patient
53 YR
- Erythema
- Skin Discoloration
Narrative
Description of Event or Problem
PT HAD HYBRESIS/IONTOPHORESIS AT LAST PT VISIT (B)(6) 2010 - 10TH INTO TREATMENT, USING HYBRESIS 9 OUT OF 10 TIMES-. PT REPORTS THAT SHE LEFT THAT PATCH ON FOR THE ALLOCATED 2 HOURS FOLLOWING HER TREATMENT SESSION, WHEN SHE TOOK THE PATCH OFF SHE REPORTS THAT THE ELECTRODE WAS BLACK AND DISCOLORED. LATER HER SKIN PIGMENTATION DARKENED/REDDENED IN THE AREA WHERE THE PATCH HAD BEEN. PATCH WAS THROWN AWAY BY PT.