MACRODUCT SYSTEM (SWEAT CHLORIDE TEST/ PILOGEL DISCS)
Received Feb 3, 2009 · Event occurred Feb 2, 2009
Report 1311849 · MDR key 1311849
Device
Generic name
Device, Iontophoresis
Manufacturer
Wescor, Inc.Model number
*Catalog number
SS-023
Lot number
100754
Product problems
- Unknown (for use when the device problem is not known)
Patient
7 MO
- Bruise/Contusion
- Emotional Changes
- Erythema
- Treatment with medication(s)
Narrative
Description of Event or Problem
AN INFANT PATIENT UNDERWENT SWEAT A CHLORIDE TEST TO RIGHT ARM PER LAB TECHNICIAN. PT STARTED TO CRY DURING FIVE MINUTE TEST. RN REMOVED BAND AND ELECTRODES FROM RIGHT ARM. THE RIGHT HAND WAS BLUISH IN COLOR UNTIL IMMEDIATELTY AFTER BAND RELEASED. A HALF DOLLAR SIZE AREA OF REDNESS WAS NOTED ON RIGHT ANTERIOR FOREARM WITH FOUR SMALL PINPOINT AREAS OF BROWNISH BLUE SKIN. INDENTATION WAS NOTED TO RIGHT WRIST FROM BLACK BAND. PEDIATRICIAN NOTIFIED. THE AFFECTED AREA WAS IMMEDIATELY CLEANSED WITH STERILE WATER. NEOSPORIN APPLIED AND THEN DRESSED WITH KERLIX GAUZE DRESSING.====================== MANUFACTURER RESPONSE FOR SWEAT CHLORIDE TEST/ PILOGEL DISCS, WESCOR MACRODUCT SYSTEM======================I TALKED WITH MFR WHO WILL BE SENDING A LOANER UNIT. HE ALSO RECOMMENDED A PARENT EDUCATION SHEET WHICH IS INCLUDED IN A SUPPLY KIT. SEVERAL FOLLOW-UP AND USER QUESTIONS WERE DISCUSSED. I WILL FOLLOW-UP WITH THE COMPANY WHO SEEMS VERY INTERESTED IN PATIENT WELL BEING AND PATIENT SAFETY