FDA Adverse Event
Injury
Summary report: N
PERFORMER MICROPUNCTURE SHEATH INTRODUCER SET
MDR report key: 1236926
·
Received November 12, 2008
Report
- Report Number
- 1820334-2008-00611
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- April 29, 2008
- Report Date
- October 13, 2008
- Manufacturer
- COOK, INC.
- Product Code
- DYB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL: THIS EVENT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
EMERGENT SURGERY FOR ACUTE EMBOLUS. RIGHT ARM. DEVELOPED A HEMATOMA IN RIGHT GROIN AT THE SITE OF SHEATH. CUT-DOWN AT RIGHT GROING AREA, WHERE A HEMATOMA WAS REMOVED, AND SHEATH WAS FOUND TO HAVE A 3MM HOLE IN IT. PT CONDITION UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERFORMER MICROPUNCTURE SHEATH INTRODUCER SET | DYB INTRODUCER, CATHETER | DYB | COOK, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |