FDA Adverse Event
Other
Summary report: N
KWIKTRAK TRACK
MDR report key: 1971713
·
Received January 12, 2011
Report
- Report Number
- 9681684-2011-00001
- Event Type
- Other
- Date Received
- January 12, 2011
- Date of Event
- January 1, 2010
- Report Date
- December 14, 2010
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FNG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER INFORMED THE INITIAL REPORTER TO CONTACT THE END USER TO IMMEDIATELY STOP USING HIS INSTALLATION UNTIL IT IS REPAIRED. FURTHER INFORMATION WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
THE JOINTS OF THE TRACK INSTALLATION ARE OPEN 1/4 INCH. NO INCIDENT OCCURRED, THERE WAS NO PT INVOLVED, AND NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KWIKTRAK TRACK | NONE | FNG | BHM MEDICAL, INC. | 9100001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |