FDA Adverse Event
Injury
Summary report: N
WITTICH NITINOL STONE BASKET
MDR report key: 1011896
·
Received March 11, 2008
Report
- Report Number
- 1820334-2008-00115
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 13, 2008
- Manufacturer
- COOK, INC.
- Product Code
- LQR
- PMA / PMN Number
- K902944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
DURING A PERCUTANEOUS NEPHROSTOMY STONE EXTRACTION IN 2008, THE STONE RETRIEVAL DEVICE BROKE OFF IN MALE PT. THE DEVICE WAS EASILY RETRIEVED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WITTICH NITINOL STONE BASKET | LQR STONE BASKET | LQR | COOK, INC. | NA | 1849588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |