inforMED
MalfunctionKTB

*

Received Aug 1, 2011 · Event occurred Jul 19, 2011

Report 2192411 · MDR key 2192411

Device

Generic name

Gel Disc For Sweat Test

Manufacturer

Wescor, Inc.

Model number

*

Catalog number

*

Lot number

200561

Product problems

  • Crack

Patient

4 MO

  • Pain
  • Caustic/Chemical Burns
  • No Code Available

Narrative

Description of Event or Problem

WHILE TECH WAS PERFORMING A SWEAT TEST ON PATIENT'S LEG, GEL DISK CRACKED AND PATIENT RECEIVED A SMALL BURN 2CMX2CM AREA. PT STARTED TO CRY, TECH CHECKED SITE AND NOTICED THIS, STOPPED TESTING, APPLIED A&D OINTMENT AND NOTIFIED RN, WHICH IN TURN NOTIFIED PHYSICIAN. THEY ORDERED BACITRACIN, THEN ORDERED SILVADENE BID.