FDA Adverse Event
Death
Summary report: N
FLOWTRON
MDR report key: 522862
·
Received April 29, 2004
Report
- Report Number
- 2431480-2004-00003
- Event Type
- Death
- Date Received
- April 29, 2004
- Report Date
- April 29, 2004
- Manufacturer
- HUNTLEIGH HEALTHCARE, INC.
- Product Code
- JOW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THREE PTS ALLEGEDLY DEVELOPED A DEEP VEIN THROMBOSIS, IN WHICH ONE POSTOPERATIVE GASTRIC BYPASS PT ALLEGEDLY HAD EXPIRED DUE TO A PULMONARY EMBOLISM. NO OTHER INFORMATION WAS MADE AVAILABLE BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOWTRON | INTERMITTENT PNEUMATIC COMPRESSION SYSTEM | JOW | HUNTLEIGH HEALTHCARE, INC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |