FDA Adverse Event
Malfunction
Summary report: N
SCD EXPRESS SLEEVE K/L MEDIUM
MDR report key: 1182015
·
Received September 26, 2008
Report
- Report Number
- 1017072-2008-00016
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 17, 2008
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
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 THAT A CUSTOMER HAD A PROBLEM WITH AN SCD SLEEVE. THE CUSTOMER STATES A PATIENT IN THE MEDICAL ICU DEVELOPED PURPLE BRUISING ABOVE THE ANKLE AFTER CONTINUOUS USE OF KENDALL SCD EXPRESS KNEE LENGTH SLEEVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCD EXPRESS SLEEVE K/L MEDIUM | SCD SLEEVE | JOW | COVIDIEN | 9529 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |