OtherEGJ
IONTOPHORESIS TREATMENT KIT
Received Sep 14, 2005 · Event occurred Aug 23, 2005
Report 2939821-2005-00007 · MDR key 635094
Device
Generic name
Iontophoresis Treatment Electrode
Manufacturer
North Coast Medical, Inc.Model number
*Catalog number
*
Lot number
4308-1
Product problems
- Unknown (for use when the device problem is not known)
Patient
61 YR
- Perforation
- Skin Irritation
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PATIENT REC'D IONTOPHORESIS TREATMENT WITH DEXAMETHASONE BY PHYSICAL THERAPIST (PT) ON RIGHT SHOULDER/ARM. NO REDNESS IMMEDIATELY AFTER TREATMENT. 4 HOURS LATER, PT CALLED AND STATED THAT THEY HAD A HOLE IN THEIR ARM. THE FOLLOWING DAY, PT REC'D TREATMENT FROM PT FOR INCIDENT. THERAPIST NOTED MINOR SKIN BREAKDOWN ON RIGHT BICEP.
Remedial action
- Other