FDA Adverse Event Injury Summary report: N

ALLEN SIMPLE CLAMP

MDR report key: 1304684 · Received February 3, 2009

Report

Report Number: 1221538-2009-00001
Event Type: Injury
Date Received: February 3, 2009
Date of Event: November 1, 2007
Report Date: February 3, 2009
Manufacturer: ALLEN MEDICAL SYSTEMS
Product Code: FWZ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THE EVENT WAS NOT REPORTED TO ALLEN UNTIL MORE THAN A YEAR AFTER IT OCCURRED. PHOTOGRAPHS WERE RECEIVED FROM THE ATTORNEY AND DEPICT A HEAVILY WORN, HIGHLY DAMAGED, NON-FUNCTIONAL CLAMP. THE CLAMP WAS FIVE YEARS OLD AND HEAVILY WORN AT THE TIME OF THE INCIDENT. AFTER THE INCIDENT, THE CLAMP WAS TAKEN OUT OF USE. THE DEVICE WAS NEVER RETURNED FOR EVALUATION. HEALTH CARE PROVIDERS AND HOSPITAL STAFF INVOLVED IN THE CASE, AND WHO WITNESSED THE EVENT WERE NOT MADE AVAILABLE FOR COMMUNICATION.

Description of Event or Problem · 1

IN EARLY 2009, ALLEN MEDICAL WAS CALLED BY AN ATTORNEY REPRESENTING THE HOSPITAL. THE HOSPITAL IS CURRENTLY INVOLVED IN LITIGATION WITH A FORMER PATIENT DUE TO A 2007 INCIDENT WHICH ALLEGEDLY RESULTED IN INJURY. DURING THE 2007 CASE, WHICH WAS NOT PREVIOUSLY REPORTED TO ALLEN MEDICAL, AN ALLEN CLAMP MANUFACTURED IN 2002 WAS REPORTEDLY USED. ACCORDING TO THE HOSPITAL'S ATTORNEY: THE LAMP HOLDING THE STIRRUP, WHICH IN TURN, WAS SUPPORTING THE PATIENT'S LEG, CAME APART DURING THE PROCEDURE. THE PATIENT'S LEG WAS CAUGHT AND THERE WAS ONLY A BRIEF DELAY DURING WHICH TIME A NEW CLAMP WAS PUT INTO USE WITH THE STIRRUP. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. THE EXTENT OF THE INJURIES REPORTEDLY SUSTAINED BY THE PATIENT ARE UNKNOWN BY ALLEN MEDICAL AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALLEN SIMPLE CLAMP	SIMPLE CLAMP	FWZ	ALLEN MEDICAL SYSTEMS	A-40018	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Disability