InjuryEGJ
ACTIVAPATCH IONTOGO 4.0
Received Sep 6, 2016 · Event occurred Oct 19, 2015
Report 3005917950-2016-00001 · MDR key 5930930
Device
Generic name
Iontophoresis Patch
Manufacturer
Activatek, Inc.Model number
001-50Catalog number
NC89189
Lot number
BEW150102
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
46 YR
- Full thickness (Third Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
PER CUSTOMER, IONTOGO 4.0 LEFT A BLACK MARKING ON PATIENT'S SKIN ON NEGATIVE SIDE OF PATCH. BLACK MARKING THEN BLISTERED UP AND LEFT AN OPEN WOUND.