FDA Adverse Event
Injury
Summary report: N
COOK GUNTHER TULIP
MDR report key: 2030958
·
Received March 23, 2011
Report
- Report Number
- MW5019942
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- January 25, 2010
- Report Date
- March 14, 2011
- Manufacturer
- COOK
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I WENT TO THE ER ROOM. WAS TOLD THAT THEY WERE GOING TO DO ALTERNATE CATHETERIZATION TO SEE IF I HAD ANY BLOCKED ARTERY BLOCKAGE. DIAGNOSIS OR REASON FOR USE: BLOOD CLOTS IN LEGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK GUNTHER TULIP | VENA CAVA FILTER | DTK | COOK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| L| O| S | MEDS TAKEN AT TIME |