FDA Adverse Event
Malfunction
Summary report: N
MERCURY MEDICAL
MDR report key: 675921
·
Received October 6, 2004
Report
- Report Number
- 1024404-2004-00062
- Event Type
- Malfunction
- Date Received
- October 6, 2004
- Report Date
- June 30, 2004
- Manufacturer
- MERCURY MEDICAL
- Product Code
- CCW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER FACILITY CONDUCTED AN INSPECTION TO ALL BLADES AVAILABLE ON THEIR SITE, AND FOUND OUT THAT THE LIGHT BUNDLES WERE FALLING OUT, BEFORE USING IT TO THE PATIENT. NO INJURY NOR DEATH INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERCURY MEDICAL | 2001 FIBER OPTIC LARYNGOSCOPE BLADE | CCW | MERCURY MEDICAL | MILLER # 3 | A1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |