OtherEGJ

NORTH COAST MEDICAL

Received Apr 7, 2006 · Event occurred Oct 6, 2005

Report 1528764-2006-00001 · MDR key 697866

Device

Generic name

Iontophoresis Treatment Electrodes

Manufacturer

Selective Med Components, Inc.

Model number

NC89255B

Catalog number

NC89255B

Lot number

050620-800

Product problems

Unknown (for use when the device problem is not known)

Patient

35 YR

Overmedicated
Skin Irritation

Narrative

Description of Event or Problem

SAME AS REPORTED BY DISTRIBUTOR, NORTH COAST MEDICAL, INC. 12/05, MFR. REPORT # 2939821-2005-00008. NOT REPORTED TO MFR SELECTIVE MED COMPONENTS, INC., UNTIL 3/06. AFTER IONTOPHORESIS TREATMENT: "SKIN IRRITATION", "REQUIRED MEDICAL TREATMENT FOR THE REACTION." NOTE: TREATMENT DOSE EXCEEDED MAXIMUM RECOMMENDED DOSAGE.