FDA Adverse Event
Injury
Summary report: N
IMPLANTED POWERPICC
MDR report key: 2113562
·
Received June 1, 2011
Report
- Report Number
- 3006260740-2011-00160
- Event Type
- Injury
- Date Received
- June 1, 2011
- Report Date
- May 11, 2011
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- LJS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
FACILITY HAD A COMPLICATION WHICH REQUIRED INTERVENTIONAL RADIOLOGY TO REMOVE THE GUIDEWIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTED POWERPICC | PERCUTANEOUS, IMPLANTED LONG TERM INTRAVASCULAR CATHETER | LJS | C. R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Required Intervention |