FDA Adverse Event
Injury
Summary report: N
ETHICON ENDO-SURGERY INC
MDR report key: 767972
·
Received November 14, 2005
Report
- Report Number
- 767972
- Event Type
- Injury
- Date Received
- November 14, 2005
- Date of Event
- July 29, 2005
- Report Date
- November 1, 2005
- Manufacturer
- ETHICON ENDO-SURGERY INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS PUTTING THE LAP DISC INTO THE PT'S WOUND AND IT "JUST PULLED APART WITHOUT HARDLY ANY STRESS".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY INC | 1 LAP DISC | GCJ | ETHICON ENDO-SURGERY INC. | LD 111 | 050303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |