MACRODUCT
Received Jun 19, 2007 · Event occurred Jun 7, 2007
Report 871066 · MDR key 871066
Device
Generic name
Sweat Collection System
Manufacturer
Wescor, Inc.Model number
3700Catalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
12 DAY
- Burn(s)
- Skin Discoloration
- Hospitalization required
Narrative
Description of Event or Problem
PATIENT WAS SEEN FOR A SWEAT CHLORIDE TEST. THE CAUSE IS UNKNOWN, HOWEVER PATIENT SUSTAINED AN INJURY TO HIS ARM WHERE THE PILOGEL DISC/ELECTRODE WAS PLACED TO PERFORM THE TEST. THIS REACTION WAS DISCOVERED AFTER THE FIVE-MINUTE SWEAT STIMULATION WAS COMPLETED AND PILOGEL DISC WAS REMOVED. PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT. IT WAS NOTED THAT THE PATIENT HAD A 2-3MM LESION THAT WAS DARK IN COLOR AND APPEARED TO BE CONSISTENT WITH A BURN. THE MARCODUCT SYSTEM WAS EVALUATED BY THE BIOMED DEPARTMENT AND DETERMINED TO OPERATE AS DESIGNED.