FDA Adverse Event
Injury
Summary report: N
ATS 3000 TOURNIQUET
MDR report key: 2091657
·
Received April 28, 2011
Report
- Report Number
- 1526350-2011-00077
- Event Type
- Injury
- Date Received
- April 28, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 30, 2011
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- KCY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ZIMMER ATS 3000 WAS USED IN A PROCEDURE WHERE THE SURGEON WAS REVISING A CLOSURE OF A LOWER EXTREMITY AMPUTATION. BLEEDING OCCURRED DURING THE PROCEDURE. THE TOURNIQUET WAS NOTED TO HAVE BEEN APPLIED TOO TIGHTLY PRIOR TO EXSANGUINATION OF LIMB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATS 3000 TOURNIQUET | ATS 3000 TOURNIQUET | KCY | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |