FDA Adverse Event Injury Summary report: N

LASER FLEX

MDR report key: 185143 · Received August 25, 1998

Report

Report Number
185143
Event Type
Injury
Date Received
August 25, 1998
Date of Event
July 1, 1998
Report Date
August 18, 1998
Manufacturer
MALLINCKRODT MEDICAL
Product Code
BTR
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

FACILITY REPORTED, "CUFF WOULD NOT DEFLATE, COULDN'T EXTUBATE, HAD TO DO A DIRECT LARYNGOSCOPY."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LASER FLEX ENDOTRACHEAL TUBE BTR MALLINCKRODT MEDICAL NA ML07760

Patients

Seq Age Sex Outcome Treatment
1 54 YR Other| R