FDA Adverse Event
Malfunction
Summary report: N
ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE
MDR report key: 2517963
·
Received April 2, 2012
Report
- Report Number
- 1222895-2012-00009
- Event Type
- Malfunction
- Date Received
- April 2, 2012
- Date of Event
- March 9, 2012
- Report Date
- April 2, 2012
- Manufacturer
- INTEGRA BURLINGTON, MA, INC
- Product Code
- FST
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
THE DOCTOR WAS PERFORMING A CORONARY ARTERY BYPASS GRAFT AND WORE THE HEADLIGHT FOR 1.5 TO 2 HOURS BEFORE HE NOTICED THE 2ND DEGREE BURN ON THE BRIDGE OF HIS NOSE, JUST UNDER THE BOTTOM ARCH OF THE MODULE. THE BURN WAS TREATED WITH OINTMENT AND A WOUND DRESSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE | IMIG | FST | INTEGRA BURLINGTON, MA, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00MLX LIGHT SOURCE - SERIAL # (B)(4) |