FDA Adverse Event
Injury
Summary report: N
ETHICON
MDR report key: 291183
·
Received August 17, 2000
Report
- Report Number
- 291183
- Event Type
- Injury
- Date Received
- August 17, 2000
- Date of Event
- August 15, 2000
- Report Date
- August 16, 2000
- Manufacturer
- ETHICON INC
- Product Code
- GAN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING TOTAL ABDOMINAL HYSTERECTOMY TIP OF SUTURE NEEDLE SNAPPED OFF REQUIRING RETRIEVAL. PHYSICIAN ABLE TO RETRIEVE WITH NO ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON | SUTURE | GAN | ETHICON INC | * | OUTER WRAPPER NOT KEPT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |