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 |