MalfunctionKIP
HANKS BALANCED SALT SOLUTION
Received Apr 4, 2017 · Event occurred Jan 6, 2017
Report MW5068887 · MDR key 6459750
Device
Product problems
- Microbial Contamination of Device
Patient
Not reported
- Bacterial Infection
- Bacterial Infection
Narrative
Description of Event or Problem
RARE FUNGUS SEEN ON PATHOLOGY RESULTS FOR 4 PATIENTS CRYPTOCOCCUS ADELIENSIS. LITERATURE SEARCH REVEALED THAT THIS FUNGUS CAN BE SEEN AS CONTAMINANT IN HANKS SOLUTION WHICH WAS USED IN ALL 4 BIOPSIES. THERAPY START DATE: (B)(6) 2017. THERAPY END DATE: (B)(6) 2017. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.