InjuryLHC
ECO LAB MICROTEK MEDICAL INC.
Received Nov 1, 2018 · Event occurred Sep 27, 2018
Report MW5081015 · MDR key 8032940
Device
Generic name
Eco Lab, Microtek Medical Inc, Warmer, Irrigation, Solution
Manufacturer
Eco Lab / Microtek Medical Inc.Lot number
D180969
Product problems
- Fluid/Blood Leak
- Material Puncture/Hole
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WARMER DRAPE USED FOR IRRIGATION FLUID. AT END OF CASE WHEN DRAPE REMOVED, DISCOVERED FLUID IN THE WARMER PAN. THE WARMER DRAPE HAD A HOLE AND THERE WAS COMMUNICATION BETWEEN THE UNSTERILE METAL RECEPTACLE AND THE IRRIGATION FLUID. THE PRODUCT IS NOT COMPOUNDED; THE PRODUCT IS NOT OVER-THE-COUNTER.