FDA Adverse Event
Death
Summary report: N
KENDALL SEQUENTIA COMPRESSION SYSTEM
MDR report key: 620317
·
Received July 11, 2005
Report
- Report Number
- 1310379-2005-00008
- Event Type
- Death
- Date Received
- July 11, 2005
- Date of Event
- June 14, 2005
- Report Date
- July 11, 2005
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- JOW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CUSTOMER HAD A PROBLEM WITH SEQUENTIAL COMPRESSION SLEEVES. ACCORDING TO THE CUSTOMER, "9 DAYS AFTER A SURGERY, A PT DIED (PULMONARY EMBOLISM AS RELATED BY THE HOSPITAL). THE PROPHYLAXIS USED WAS: SCD AND HEPARIN (LMWH)"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENDALL SEQUENTIA COMPRESSION SYSTEM | SEQUENTIAL COMPRESSION CONTROLLER | JOW | TYCO HEALTHCARE/KENDALL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |