FDA Adverse Event
Injury
Summary report: N
PUMP/SHAVER CHASSIS
MDR report key: 321628
·
Received March 16, 2001
Report
- Report Number
- 2950285-2001-00001
- Event Type
- Injury
- Date Received
- March 16, 2001
- Date of Event
- February 20, 2001
- Report Date
- March 16, 2001
- Manufacturer
- ARTHROTEK, INC.
- Product Code
- HRX
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ARTHROSCOPIC MENISCECTOMY PERFORMED ON LEFT KNEE. FOLLOWING RELEASE OF THIGH TOURNIQUET, CIRCULATION DID NOT NORMALLY RETURN TO LOWER EXTREMITY. FASCIOTOMY WAS THEN PERFORMED WHICH RESTORED PULSE TO LOWER LEG AND FOOT. NO ADDITIONAL COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11838 | PUMP/SHAVER CHASSIS | INTERGRATED ENDOSCOPY SYSTEM | HRX | ARTHROTEK, INC. | NA | 10047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |