FDA Adverse Event
Other
Summary report: N
TRANSMOTION MEDICAL, INC.
MDR report key: 2823721
·
Received October 24, 2012
Report
- Report Number
- 3004082462-2012-00003
- Event Type
- Other
- Date Received
- October 24, 2012
- Date of Event
- September 28, 2012
- Report Date
- October 23, 2012
- Manufacturer
- TRANSMOTION MEDICAL INC.
- Product Code
- GBB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TMM'S SALES REPRESENTATIVE WENT TO THE FACILITY TO REVIEW THE SITUATION (B)(4) 2012. IT WAS CLEAR THE FACILITY DIDN'T USE THE PROPER ACCESSORY (BACK REST EXTENSION) THAT IS USED FOR TRANSPORT. THE BACK REST EXTENSION WAS FOUND BY THE STAFF IN THE CLOSET. THE STAFF WAS RETRAINED ON THE IMPORTANCE OF USING THE DEVICE AS IT WAS DESIGNED FOR SAFE AND PROPER USE. THERE WAS NO DEFICIENCIES WITH THE PRODUCT.
Description of Event or Problem · 1
AT (B)(6) HOSPITAL, THE TRANSPORT DEPARTMENT WENT UP TO THE ROOM TO GET A STROKE PT TO TRANSPORT IN THE TMM3 CHAIR FOR HER VIDEO SWALLOW STUDY PROCEDURE. THEY SAT HER UP SHE FELL THROUGH THE BACK OF THE CHAIR, AND IT WAS STATED THAT SHE "CUT HER HEAD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSMOTION MEDICAL, INC. | TMM3 VIDEO SWALLOW STUDY CHAIR | GBB | TRANSMOTION MEDICAL INC. | TMM3-B | 1532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| R |