FDA Adverse Event
Other
Summary report: N
PUMP, CONTINUOUS WAVE II
MDR report key: 1023855
·
Received March 31, 2008
Report
- Report Number
- 1220246-2008-00053
- Event Type
- Other
- Date Received
- March 31, 2008
- Date of Event
- January 1, 2008
- Report Date
- March 6, 2008
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP RAN CONTINUOUSLY DURING A SHOULDER PROCEDURE. THE PT SUFFERED INNER COMPARTMENT SYNDROME AND THE PROCEDURE WAS ABORTED. THE COMPARTMENT SYNDROME RESOLVED NATURALLY, HOWEVER, THE PT WAS RE-INTERVENED 4 WEEKS LATER TO COMPLETE THE INITIAL REPAIR. IT WAS ALSO REPORTED THAT THE PT HAD RECOVERED WELL. NO FURTHER PT INFO IS AVAILABLE AND NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP, CONTINUOUS WAVE II | ARTHROSCOPIC PUMP | HRX | ARTHREX, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other |