MalfunctionKTB
IONTOPHORESIS SWEAT CHLORIDE GIBSON COOKE SWEAT TEST APPARAT
Received Jan 9, 2007 · Event occurred Dec 1, 2006
Report 813719 · MDR key 813719
Device
Generic name
Sensor, Sweat Tester
Manufacturer
Farrall InstrumentsModel number
*Catalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
22 MO
- Dural Tear
- Skin Discoloration
- Swelling
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT UNDERGOING SWEAT TESTING (IONTOPHORESIS - SWEAT CHLORIDE.) RIGHT ARM TESTED WITHOUT DIFFICULTY. DURING TEST OF LEFT ARM, CHILD BEGAN TO CRY. WHEN THE ELECTRODE WAS REMOVED, THE ARM APPEARED TO BE BURNED WITH BLACK PINHOLE MARKS AND WELTS ON ARM UNDER ELECTRODE AREA AND OUT FROM AROUND ELECTRODES.