FDA Adverse Event
Injury
Summary report: N
AUTO SUTURE CHEMOSITE MINI CATHETER POLYURETHANE SYSTEM
MDR report key: 117828
·
Received September 5, 1997
Report
- Report Number
- 1219161-1997-01188
- Event Type
- Injury
- Date Received
- September 5, 1997
- Date of Event
- January 1, 1997
- Report Date
- August 6, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
11/12/1997-SUPPLEMENT #2 SENT TO FDA.
Description of Event or Problem · 1
THE PRODUCT WAS IMPLANTED ON 11/21/1996. REPORTEDLY, THE CATHETER BROKE. THE SURGEON PERFORMED A REOPERATION TO REMOVE THE DEVICE AND IMPLANT ANOTHER ONE. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE CHEMOSITE MINI CATHETER POLYURETHANE SYSTEM | IMPANTABLE VENOUS ACCESS SYSTEM | LJT | UNITED STATES SURGICAL CORPORATION | NA | C6A06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |