FDA Adverse Event Malfunction Summary report: N

AMBU PERFIT COLLAR

MDR report key: 7901376 · Received September 24, 2018

Report

Report Number
7901376
Event Type
Malfunction
Date Received
September 24, 2018
Date of Event
August 7, 2018
Report Date
September 7, 2018
Manufacturer
CORFLEX
Product Code
IQK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

MIDDLE AGED PATIENT COLLAPSED ON THE GROUND IN THE HOSPITAL UNIT. A CODE HEAD BLEED AND A CODE BLUE WERE CALLED AND THE PATIENT WAS PLACED IN CERVICAL COLLAR, PLACED ON A STRETCHER, AND TRANSFERRED RAPIDLY TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT REMAINED IN THE ICU FOR TREATMENT CARDIAC ARREST SECONDARY TO AN ACUTE PULMONARY EMBOLUS. HE REMAINED IN A COLLAR. SEVERAL DAYS LATER, THE PATIENT COMPLAINED OF MILD PAIN FROM AN ABRASION ON THE BACK OF HIS HEAD. THE WOUND WAS ASSESSED, AND NO DRAINAGE WAS NOTED. THE WOUND NURSE WAS CONSULTED. THE WOUND NURSE WAS CONSULTED FOR TWO AREAS OF REDNESS, ON THE PATIENT'S SHOULDER AND HEAD, LIKELY RELATED TO THE C-SPINE COLLAR. BOTH AREAS APPEARED TO BE UNSTAGEABLE. THE PRESUMED UNDERLYING ETIOLOGY AS PRESSURE RELATED TO THE RIGID SPINAL COLLAR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
744346 AMBU PERFIT COLLAR ORTHOSIS, CERVICAL IQK CORFLEX 19-9007

Patients

Seq Age Sex Outcome Treatment
1 20440 DA Other