OtherEGJ
IONTOPHORESIS TREATMENT KIT, BUTTERFLY (12)
Received Dec 21, 2005 · Event occurred Oct 6, 2005
Report 2939821-2005-00008 · MDR key 656042
Device
Generic name
Iontophoresis Treatment Electrodes
Manufacturer
Selective Med Components Inc.Model number
NC89255BCatalog number
NC89255B
Lot number
050620-800
Product problems
- Use of Device Problem
Patient
35 YR
- Blister(s)
- Erythema
- Overdose
- Skin Irritation
Narrative
Description of Event or Problem
PT RECEIVED IONTOPHORESIS TREATMENT BY PHYSICAL THERAPIST (PT). TREATMENT GIVEN ON ANKLE FOR A LIGAMENT SPRAIN. PT DEVELOPED BLISTERING AND REDNESS AFTER TREATMENT. WITHIN 1 WEEK, PT WAS TREATED AGAIN ON ANKLE. REACTION WAS THE SAME. PT NOTED THAT TREATMENT DOSAGE EXCEEDED MAXIMUM RECOMMENDED DOSE OF 40MA-MIN.
Remedial action
- Other