FDA Adverse Event
Malfunction
Summary report: N
PORT TITANIUM WITH GROSHONG
MDR report key: 23919
·
Received July 8, 1995
Report
- Report Number
- 23919
- Event Type
- Malfunction
- Date Received
- July 8, 1995
- Date of Event
- May 26, 1995
- Report Date
- June 6, 1995
- Manufacturer
- DAVOL, INC.
- Product Code
- LJK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PT WAS ADMITTED FOR OUTPATIENT SURGERY TO REMOVE THE PORT-A-CATH. THE CATHETER HAD FRAGMENTED AND WAS RETRIEVED IN APRIL BUT THE PT WAS NOT STABLE AT THE TIME FOR SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORT TITANIUM WITH GROSHONG Implant | PORT A CATH | LJK | DAVOL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |