FDA Adverse Event
Malfunction
Summary report: N
LARYNGOSCOPE BLADE
MDR report key: 65815
·
Received January 31, 1997
Report
- Report Number
- MW1010643
- Event Type
- Malfunction
- Date Received
- January 31, 1997
- Report Date
- January 21, 1997
- Manufacturer
- PROPPER MFG CO, INC.
- Product Code
- EQN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IDENTIFICATION OF MULTIPLE ONGOING PROBLEMS WITH LARYNGOSCOPE BLADES AND HANDLES. BLADES REQUIRE RE-PLATING, HANDLES ARE DEFECTIVE AND WELD OF BLADE IS SEPARATING AND CREATING A SHARP EDGE/POINT PREVENTING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LARYNGOSCOPE BLADE | LARYNGOSCOPE BLADE | EQN | PROPPER MFG CO, INC. | 199145 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |