MalfunctionKKO
THE FIRST YEAR
Received Apr 6, 2006 · Event occurred Apr 5, 2006
Report MW1038439 · MDR key 698943
Device
Product problems
- Fluid/Blood Leak
- Nonstandard Device
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
FLUID LEAKED UNDER NORMAL USE BY PT. APPROXIMATELY 1-2 TABLESPOONS OF LIQUID INGESTED. -AFTER INCIDENT, LEARNED THAT PRODUCT IS UNDER RECALL: SEE FDA RECALL NOTICE P06-21 DATES 02/09/06. POISON CONTROL, PEDIATRICIAN CONTACTED. NO ADVERSE REACTIONS 14 HOURS AFTER EVENT.