FDA Adverse Event
Injury
Summary report: N
2PC VSYS W/9FR INTR KIT LW PFL
MDR report key: 6176825
·
Received December 15, 2016
Report
- Report Number
- 1219930-2016-01354
- Event Type
- Injury
- Date Received
- December 15, 2016
- Date of Event
- November 3, 2016
- Report Date
- November 28, 2016
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- LJS
- PMA / PMN Number
- K961856
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: PORT-A IMPLANTATION. PER ADDITIONAL INFORMATION RECEIVED, ACCORDING TO THE REPORTER, THERE WAS TISSUE DAMAGE. THE PATIENT FELT PAINFUL AROUND THE PORT-A IMPLANTATION REGION. AFTER AN X-RAY, THEY FOUND THE CATHETER WAS FRACTURED. THE SURGEON HAD TO REMOVE THE PORT-A AND RE-IMPLANT A NEW ONE. THE DAMAGE WAS NOT PERMANENT.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE BROKE. ANOTHER OPERATION WAS REQUIRED TO REMOVE THE DEVICE. THE PATIENT IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829751 | 2PC VSYS W/9FR INTR KIT LW PFL | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 120021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |