ECOLAB
Received Apr 6, 2016 · Event occurred Feb 17, 2016
Report 1047429-2016-00010 · MDR key 5551459
Device
Product problems
- Hole In Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # ORS-300N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(4) 2016 ORIGINATED BY (B)(6), STATING A HOLE IN THE WARMER DRAPE WAS NOTICED AT THE END OF THE CASE. THE DRAPE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED. AVID MEDICAL ISSUED FORMAL COMPLAINT (B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE WARMER DRAPE - PART # ORS-300N. THE WARMER DRAPE LOT # D151381RHVO; D152781; D152751.