FDA Adverse Event
Injury
Summary report: N
SCD EXPRESS SLEEVE K/L MEDIUM
MDR report key: 1413392
·
Received July 9, 2009
Report
- Report Number
- 1017072-2009-00004
- Event Type
- Injury
- Date Received
- July 9, 2009
- Report Date
- June 12, 2009
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN IN 2009 THAT A CUSTOMER HAD AN ISSUE WITH A SEQUENTIAL COMPRESSION SLEEVE. CUSTOMER STATES THAT THE PT DEVELOPED COMPARTMENT SYNDROME AFTER A THORACIC SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCD EXPRESS SLEEVE K/L MEDIUM | SEQUENTIAL COMPRESSION SLEEVE | JOW | COVIDIEN | 9529 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |