InjuryEGJ
UNKNOWN EMPI IONTOPHORESIS DEVICE
Received Dec 15, 2008 · Event occurred Jul 3, 2008
Report 2182686-2008-00007 · MDR key 1270525
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- Burn, Thermal
- Treatment with medication(s)
Narrative
Description of Event or Problem
IN 2008, PT REPORTED HE RECEIVED A BURN THE SIZE OF THE NICKEL UNDER THE PATCH AFTER IONTOPHORESIS TREATMENT. ON FOUR DAYS LATER, THE PATIENT REPORTED THAT BURN HAS WORSENED AND HIS PHYSICIAN ASSISTANT GAVE HIM A TRIPLE-ANTIBACTERIAL OINTMENT TO APPLY TO THE BURN. THE PT RETURNED THE PATCH TO HIS PHYSICIAN AND IT WAS DISPOSED OF. IT IS UNK WHICH TYPE OF EMPI IONTOPHORESIS DEVICE WAS INVOLVED.
Additional Manufacturer Narrative
THE INVESTIGATION OF THIS EVENT IS ONGOING AND A SUPPLEMENTAL REPORT MAY BE SUBMITTED IF MATERIAL INFO IS DISCOVERED.
Remedial action
- Patient Monitoring