ECOLAB
Received Jan 21, 2016 · Event occurred Dec 14, 2015
Report 1047429-2016-00005 · MDR key 5383011
Product problems
- Hole In Material
Patient
70
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence 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-100N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2015 ORIGINATED BY (B)(6) MEDICAL CENTER STATING A HOLE IN THE WARMER DRAPE WAS DISCOVERED AT THE END OF THE CASE. THE COMPLAINED DRAPE WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE WARMER DRAPE - PART # ORS-100N. THE WARMER DRAPE LOT # IS NOT KNOWN. ARRANGEMENTS WERE MADE BY ECOLAB TO RETRIEVE THE COMPLAINED DRAPE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.