FDA Adverse Event
Injury
Summary report: N
ANGIODYNAMICS INC PORT SMRT 8 0FR W/VALVED INTRO PORT A CATH
MDR report key: 18311533
·
Received December 11, 2023
Report
- Report Number
- MW5149129
- Event Type
- Injury
- Date Received
- December 11, 2023
- Date of Event
- December 7, 2023
- Report Date
- December 8, 2023
- Manufacturer
- ANGIODYNAMICS INC.
- Product Code
- LJT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PT REQUIRED VASCULAR INTERVENTIONAL PROCEDURE TO REMOVE BROKEN PORT. XRAY DONE AT ANOTHER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841006 | ANGIODYNAMICS INC PORT SMRT 8 0FR W/VALVED INTRO PORT A CATH | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | LJT | ANGIODYNAMICS INC. | CT80STPD-VI | 5163658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |