FDA Adverse Event
Malfunction
Summary report: N
BLADE EXTENDER FOR ADULT LARYNGOSCOPE, 6/PKG
MDR report key: 1191569
·
Received July 23, 2008
Report
- Report Number
- 1519132-2008-00011
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- April 22, 2008
- Report Date
- July 21, 2008
- Manufacturer
- GYRUS ACMI, INC. - NORWALK
- Product Code
- CCW
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLADE EXTENDER FOR ADULT LARYNGOSCOPE, 6/PKG | LARYNGOSCOPE BLADE EXTENDER | CCW | GYRUS ACMI, INC. - NORWALK | LAR-AE | 8078021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |