FDA Adverse Event
Injury
Summary report: N
ETHICON
MDR report key: 266861
·
Received February 8, 2000
Report
- Report Number
- 266861
- Event Type
- Injury
- Date Received
- February 8, 2000
- Date of Event
- March 16, 1999
- Report Date
- April 2, 1999
- Manufacturer
- ETHICON ENDOSURGERY J/J CO
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SMALL PIECE OF PLASTIC DISLODGED INTO ABDOMEN. STAPLE LINE OPENED SPILLING FECAL MATERIAL INTO ABDOMINAL CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON | TIA | GAG | ETHICON ENDOSURGERY J/J CO | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |