FDA Adverse Event
Injury
Summary report: N
AUTO SUTURE CHEMOSITE
MDR report key: 38452
·
Received September 12, 1996
Report
- Report Number
- 1219161-1996-00063
- Event Type
- Injury
- Date Received
- September 12, 1996
- Date of Event
- August 2, 1996
- Report Date
- September 12, 1996
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- KJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED AS AN ACCESS PORT. REPORTEDLY, SEVEN MONTHS AFTER IT WAS IMPLANTED A CRACK WAS NOTICED IN THE CATHETER. THE SURGEON IMPLANTED A NEW PORT SYSTEM. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE CHEMOSITE Implant | IMPLANTABLE ACCESS SYSTEM | KJT | UNITED STATES SURGICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |