FDA Adverse Event
Injury
Summary report: N
FLOW TRON EXCEL
MDR report key: 519550
·
Received April 7, 2004
Report
- Report Number
- 2431480-2004-00002
- Event Type
- Injury
- Date Received
- April 7, 2004
- Report Date
- April 7, 2004
- Manufacturer
- HUNTLEIGH HEALTHCARE, INC.
- Product Code
- JOW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A HOSPITAL BIOMEDICAL TECHNICIAN INFORMED HUNTLEIGH HEALTHCARE THAT A PT WAS DIAGNOSED WITH A STRESS FRACTURE SEVERAL MONTHS POST-DISCHARGE. THE FLOWTRON EXCEL (AC550) INTERMITTENT PNEUMATIC COMPRESSION SYSTEM HAD BEEN UTILIZED DURING THE HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOW TRON EXCEL | INT. PNEUMATIC COMPRESSION | JOW | HUNTLEIGH HEALTHCARE, INC. | AC550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |