ECOLAB

Report

• Report Number: 1047429-2016-00006
• Date Received: January 21, 2016
• Report Date: January 21, 2016
• Manufacturer: ECOLAB
• Product Code: LHC
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: CA, 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 (B)(4). AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2015 ORIGINATED BY (B)(6) REPORTING A TEAR IN A WARMER DRAPE. THE COMPLAINED DRAPE WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER (B)(4) STATING A WARMER DRAPE TORE - PART # ORS-300N. THE FOLLOWING WARMER DRAPE LOT #'S WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY D151391RC, D151401RC, DA152591, D152651, D152661. ARRANGEMENTS WERE MADE BY (B)(4) TO RETRIEVE THE COMPLAINED DRAPE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
43024	ECOLAB	WARMER DRAPE	LHC	ECOLAB	ORS-300N	D151391RC, D151401RC, DA152591

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 1

• Torn Material

Source type · 2

• HEALTH PROFESSIONAL
• USER FACI