FDA Adverse Event
Other
Summary report: N
TMAX (MAXIMUM EXPOSURE SHOULDER POSITIONER)
MDR report key: 1000024
·
Received January 15, 2008
Report
- Report Number
- 9681741-2007-00001
- Event Type
- Other
- Date Received
- January 15, 2008
- Date of Event
- June 15, 2007
- Report Date
- January 14, 2008
- Manufacturer
- TENET MEDICAL ENGINEERING
- Product Code
- BWN
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE MFR BECAME AWARE OF THE EVENT THROUGH ONE OF OUR REGULAR SEARCHES OF THE MAUDE DATABASE. AT THIS TIME THE MFR DOES NOT HAVE ANY MORE INFO THAN THAT PROVIDED BY THE DATA BASE. THE MFR IS INVESTIGATING WITH THE FACILITY THAT INITIATED THE REPORT AS WELL AS A REP OF THE DISTRIBUTOR OF THE PRODUCT. DEVICE WAS RETURNED TO DISTRIBUTOR AND NOT TO MFR.
Description of Event or Problem · 1
EVENT WAS ORIGINALLY DESCRIBED BY FACILITY AND ENTERED INTO MAUDE SYSTEM. MANUFACTURER WAS NOT AWARE OF THE EVENT UNTIL A RANDOM REVIEW OF THE FDA'S MAUDE DATA BASE. MANUFACTURER IS NOW REVIEWING THE EVENT AND COLLECTING INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TMAX (MAXIMUM EXPOSURE SHOULDER POSITIONER) | BEACH CHAIR | BWN | TENET MEDICAL ENGINEERING | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |