FDA Adverse Event Death Summary report: N

CHICK ULTRALUX SURGICAL LIGHTING SYSTEM

MDR report key: 10310 · Received October 4, 1993

Report

Report Number
10310
Event Type
Death
Date Received
October 4, 1993
Date of Event
August 13, 1993
Report Date
September 30, 1993
Manufacturer
MIDMARK CORP.
Product Code
FQP
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THIS PT UNDERWENT A LENGTHY SURGICAL PROCEDURE AND POST-OPERATIVELY HAD A VERY UNUSUAL COURSE. SUBSEQUENT TO THE PT'S DEATH, IT WAS DISCOVERED THAT TWO OF THE INFRARED FILTERS WERE MISSING FROM THE SURGICAL LIGHT USED DURING THE PT'S SURGERY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CHICK ULTRALUX SURGICAL LIGHTING SYSTEM SURGICAL LIGHTING SYSTEM FQP MIDMARK CORP. 79320

Patients

Seq Age Sex Outcome Treatment
1 31 YR Death