FDA Adverse Event
Summary report: N
AUTO SUTURE CHEMOSITE
MDR report key: 34011
·
Received June 17, 1996
Report
- Report Number
- 34011
- Date Received
- June 17, 1996
- Date of Event
- June 13, 1996
- Report Date
- June 17, 1996
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- LJT
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON 4/17/96, PT HAD PORT INSERTED. RE:PT DX BREAST CARCINOMA; REQUIRING VENOUS ACCESS/MED. PT WAS ADMITTED TO HOSP 6/13/96; HX PT RECEIVING CHEMOTHERAPY. ONE WEEK AGO A LEAK FROM THE PORT WAS OBSERVED. ON 6/12/96, SHE WAS FEBRILE 100% DEGREES FAHRENHEIT. C/O PAIN AROUND PORT SITE. THE DECISION WAS MADE TO REMOVE THE PORT DUE TO POSSIBLE INFECTION. DURING SURGICAL PROCEDURE, (THE REMOVAL OF DEVICE), IT WAS NOTED THAT THE CATHETER APPEARED SHEARED OFF IN PT; EDGES IRREGULAR. CHEST X-RAY DONE PT TO ICU; TRANSFERRED TO ANOTHER MED CTR FOR REMOVAL OF CATH TIP; PT RETURNED TO HOSP 6/13-2400. PT DISCHARGED TO HOME IN THE AM OF 6/14/96.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE CHEMOSITE | IMPLANTABLE VENOUS ACCESS SYSTEM WITH POLYURETHANE CATHETER | LJT | UNITED STATES SURGICAL CORP. | NA | N5 M175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |