FDA Adverse Event
Other
Summary report: N
KENDAL SEQUENTIAL COMPRESSION DEVICE
MDR report key: 629402
·
Received August 18, 2005
Report
- Report Number
- 1310379-2005-00011
- Event Type
- Other
- Date Received
- August 18, 2005
- Date of Event
- July 20, 2005
- Report Date
- July 21, 2005
- Manufacturer
- TYCO HEALTHCARE / KENDALL
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE / KENDALL IN 2005 THAT A CUSTOMER HAD A PROBLEM WITH A SEQUENTIAL COMPRESSION SLEEVE. ACCORDING TO THE CUSTOMER PATIENT WAS PLACED ON THE SCD, AFTER 12 HOURS OF USE, ECCHYMOSIS (BRUISING) WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENDAL SEQUENTIAL COMPRESSION DEVICE | SEQUENTIAL COMPRESSION SLEEVE | JOW | TYCO HEALTHCARE / KENDALL | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Other |