FDA Adverse Event
Summary report: N
ECOLAB
MDR report key: 5382922
·
Received January 21, 2016
Report
- Report Number
- 1047429-2016-00002
- Date Received
- January 21, 2016
- Report Date
- January 21, 2016
- Manufacturer
- ECOLAB
- Product Code
- LHC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43225 | ECOLAB | WARMER DRAPE | LHC | ECOLAB | ORS-300N | D152511, D152521, D152521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |