STIFNECK SELECT COLLAR

Report

• Report Number: MW1029553
• Date Received: September 26, 2003
• Date of Event: September 21, 2003
• Report Date: September 21, 2003
• Manufacturer: LAERDAL MEDICAL CORP
• Product Code: IQK
• Report Source: Voluntary report
• Reporter Location: IA, US
• Reporter Occupation: PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS IS TO REPORT A POSSIBLE FAILURE OF A MEDICAL DEVICE. UPON ARRIVAL OF A PT TO THE HOSPITAL, IT WAS NOTED THAT YELLOW PORTION OF THE STIFNECK SELECT COLLAR, MANUFACTURED BY LAERDAL MEDICAL CORP., WAS NO LONGER INTACT. IT HAD SEPARATED JUST LATERAL TO THE RIGHT BEND WHICH ALLOWS THE COLLAR TO FIT THE CHIN. THE AMBULANCE CREW REPORTS THIS COLLAR HAD NOT PREVIOUSLY BEEN USED, AND THEY DID NOT CUT THE COLLAR. THERE WAS NO ASSOCIATED INJURY TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STIFNECK SELECT COLLAR	*	IQK	LAERDAL MEDICAL CORP	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 2

• Device Issue
• Material Separation

Type of report · 1

• Initial submission