ECOLAB
Received Jan 21, 2016
Report 1047429-2016-00002 · MDR key 5382922
Device
Product problems
- Torn Material
Patient
Not reported
- 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-300N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2015 ORIGINATED BY (B)(6) STATING A WARMER DRAPE TORE DURING SURGERY. THE COMPLAINED DRAPE WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL (B)(4) TO THE MANUFACTURER ECOLAB STATING ONE WARMER DRAPE TORE DURING SURGERY - PART # ORS-300N. THE FOLLOWING WARMER DRAPE LOT #'S WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY D152511, D152521, D152521A, D152031, D152471, D152381, D152011RC, D152021RC, D151531RC. ARRANGEMENTS WERE MADE BY ECOLAB TO RETRIEVE THE COMPLAINED DRAPE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.