FDA Adverse Event
Injury
Summary report: N
EASYSTAND BANTAM MEDIUM
MDR report key: 12310956
·
Received August 11, 2021
Report
- Report Number
- 2183634-2021-00002
- Event Type
- Injury
- Date Received
- August 11, 2021
- Date of Event
- July 12, 2021
- Report Date
- July 12, 2021
- Manufacturer
- ALTIMATE MEDICAL, INC.
- Product Code
- INO
- PMA / PMN Number
- K123834
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
ALTIMATE MEDICAL, INC. WAS INFORMED BY ONE OF THEIR SALES REPRESENTATIVES ON (B)(6) 2021 THAT A CLIENT'S FATHER CLAIMED THEIR BANTAM MEDIUM STANDER WAS "FAULTY". THE FATHER SAID THE CLIENT WAS STANDING IN IT LAST WEEK AND THE TRAY FELL OFF AND SHE FELL OUT OF IT, INJURING HERSELF. HE STATED THAT THE TRAY WAS NOT ABLE TO SECURELY ATTACH TO THE STANDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1202766 | EASYSTAND BANTAM MEDIUM | CHAIR, POSITIONING, ELECTRIC | INO | ALTIMATE MEDICAL, INC. | BANTAM MEDIUM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |