FDA Adverse Event
Malfunction
Summary report: N
PROPPER
MDR report key: 73249
·
Received February 28, 1997
Report
- Report Number
- 2410251-1997-00001
- Event Type
- Malfunction
- Date Received
- February 28, 1997
- Report Date
- February 27, 1997
- Manufacturer
- PROPPER MFG. CO., INC.
- Product Code
- EQN
- Report Source
- Manufacturer 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 REPLATING, 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 | PROPPER | #3 LARYNGOSCOPE BLADE | EQN | PROPPER MFG. CO., INC. | 199145 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |