FDA Adverse Event
Injury
Summary report: N
ETHICON
MDR report key: 1843398
·
Received September 22, 2010
Report
- Report Number
- MW5017528
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- September 16, 2010
- Report Date
- September 16, 2010
- Manufacturer
- ETHICON
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ECHELON 60 RELOAD (B)(4) LOT#64TK4U EXP 6/2015, MISFIRED DURING LAPAROSCOPIC GASTRIC BYPASS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON | ECHELON 60 VASCULAR RELOAD | GDW | ETHICON | ECR60W | 64TK4U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization |