InjuryKNM
GIBSON-COOKE SWEAT TEST APPARATUS
Received Apr 1, 2016 · Event occurred Jul 9, 2015
Report 5540657 · MDR key 5540657
Device
Generic name
Device, Iontophoresis, Specific Uses
Manufacturer
C & S Electronics, Inc.Model number
IPS-25AProduct problems
- Insufficient Device Problem Information
Patient
Not reported
- Scarring
- Skin Discoloration
- Scarring
- Skin Discoloration
Narrative
Description of Event or Problem
FOLLOWING ROUTINE SWEAT CHLORIDE TESTING WITH THE QUANTITATIVE PILOCARPINE IONTOPHORESIS PROCEDURE USING THE GIBSON COOKE SWEAT TEST APPARATUS, DARK SPOTS ON LEFT LOWER ARM WERE NOTED AFTER THE TEST WAS COMPLETE AND GAUZE WAS REMOVED. SIX MONTHS LATER, PATIENT PRESENTS WITH PERSISTENT SKIN CHANGES AND APPARENT SCARRING OF THE REGION. A THOROUGH INVESTIGATION OF THE REAGENTS, EQUIPMENT, PROCEDURE, STAFF, TRAINING, AND COMPETENCY WAS PERFORMED AND NO SPECIFIC CAUSE COULD BE IDENTIFIED.