FDA Adverse Event
Other
Summary report: N
TRANSMOTION MEDICAL, INC.
MDR report key: 2844988
·
Received November 13, 2012
Report
- Report Number
- 3004082462-2012-00005
- Event Type
- Other
- Date Received
- November 13, 2012
- Date of Event
- January 15, 2010
- Report Date
- November 7, 2012
- Manufacturer
- TRANSMOTION MEDICAL INC.
- Product Code
- GBB
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IS A RETROACTIVE REPORT BASED ON THE OBSERVATIONS AND OUR REMEDIAL ACTION. NOTHING WAS WRONG WITH THE DEVICE. IT WAS SIMPLY INCORRECTLY USED BY THE END-USER AND/OR PATIENT. WARNING LABELS WERE NOT ADHERED TO IT.
Description of Event or Problem · 1
(B)(6). CHAIR WAS IN THE BACK DOWN/LEGS UP/SIDE RAILS UP POSITION. IN THE FETAL POSITION, HE KEPT MOVING AROUND AND ULTIMATELY ENDED UP SO FAR DOWN AT THE FOOT SECTION TO THE POINT WHERE IT TIPPED. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSMOTION MEDICAL, INC. | TMM4 MULTIPURPOSE SURGICAL STRETCHER-CHA | GBB | TRANSMOTION MEDICAL INC. | TMM4-A | 2714-2718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |