FDA Adverse Event
Malfunction
Summary report: N
SCD EXPRESS SLEEVE T/L MEDIUM
MDR report key: 1052858
·
Received May 27, 2008
Report
- Report Number
- 1017072-2008-00009
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 29, 2008
- Manufacturer
- TYCO HEALTHCARE / KENDALL
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 TYCO HEALTHCARE / KENDALL THAT A CUSTOMER HAD AN ISSUE WITH AN SCD SLEEVE. THE CUSTOMER REPORTS THAT THE DR HAD A PT WHO REPORTED NUMBNESS IN THEIR LOWER EXTREMITY AFTER A ROUTINE LAPAROSCOPIC PROCEDURE. THE DR OBSERVED AND NOTICED SOME "FOOT DROP" FROM THE PT. HE DETERMINED THAT THIS WAS DUE TO OUR SLEEVE TUBING PRESSING AGAINST THE PERINEAL NERVE ON THE PT'S SHIN. HE REPORTED THAT THE PT'S FEELING HAD RETURNED AS HE TOLD THEM IT WOULD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCD EXPRESS SLEEVE T/L MEDIUM | SCD EXPRESS SLEEVE | JOW | TYCO HEALTHCARE / KENDALL | 9530 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |