FDA Adverse Event
Malfunction
Summary report: N
FOCS MACINTOSH 4 BLADE
MDR report key: 429301
·
Received November 21, 2002
Report
- Report Number
- 2429473-2002-00215
- Event Type
- Malfunction
- Date Received
- November 21, 2002
- Report Date
- November 13, 2002
- Manufacturer
- RUSCH INC.
- Product Code
- CAL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS THAT BLADE BROKE OFF IN PT'S MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOCS MACINTOSH 4 BLADE | ANESTHESIA - LARYNGOSCOPE | CAL | RUSCH INC. | NA | 116587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |