FDA Adverse Event
Injury
Summary report: N
USSC
MDR report key: 58297
·
Received August 22, 1996
Report
- Report Number
- 58297
- Event Type
- Injury
- Date Received
- August 22, 1996
- Date of Event
- March 9, 1996
- Report Date
- April 11, 1996
- Manufacturer
- AUTO SUTURE
- Product Code
- DSS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT RETURNED TO OR POST RIGHT CAORTID ENDARTERECTOMY. PHYSICIAN STATES CLIPS FELL OFF OF CAROTID ARTERY INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | USSC Implant | VASCULAR CLIP/STAPLE | DSS | AUTO SUTURE | UNK | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |