FDA Adverse Event
Injury
Summary report: N
RADISTOP RADIAL COMPRESSION SYSTEM
MDR report key: 3122491
·
Received May 14, 2013
Report
- Report Number
- 8030904-2013-00009
- Event Type
- Injury
- Date Received
- May 14, 2013
- Date of Event
- March 14, 2013
- Report Date
- April 15, 2013
- Manufacturer
- ST. JUDE MEDICAL SYSTEMS AB
- Product Code
- GAX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED; HOWEVER, WE DO NOT BELIEVE THE CAUSE OF THE HEMATOMA WAS DUE TO A DEVICE MALFUNCTION OR ANY DEFICIENCY WITH THE INSTRUCTIONS FOR USE REQUIRING CORRECTIVE ACTION. WE WILL CONTINUE TO CLOSELY MONITOR THE PERFORMANCE OF THIS PRODUCT FOR ANY SIGNIFICANT TRENDS.
Description of Event or Problem · 1
A RADISTOP COMPRESSION DEVICE WAS USED ON THE RIGHT RADIAL ARTERY. FOLLOWING USE, A HEMATOMA DEVELOPED REQUIRING SURGICAL EVACUATION. NO ADD'L INFO WAS REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212681 | RADISTOP RADIAL COMPRESSION SYSTEM | TOURNIQUET, NONPNEUMATIC | GAX | ST. JUDE MEDICAL SYSTEMS AB | C11177 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |