FDA Adverse Event
Malfunction
Summary report: N
MERCURY MEDICAL
MDR report key: 676895
·
Received October 6, 2004
Report
- Report Number
- 1024404-2004-00026
- 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
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
A LOOSE BUNDLE WAS REPORTED AND WAS INVESTIGATED BY REVIEWING ALL INFORMATION GATHERED AND FOUND THAT MALFUNCTION HAPPENED BEFORE USE. NO PATIENT INVOLVED. NO INJURY OR DEATH OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERCURY MEDICAL | 2001 FIBEROPTIC LARYNGOSCOPE BLADE | CCW | MERCURY MEDICAL | MILLER #4 | BA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |