FDA Adverse Event
Death
Summary report: N
ALLTRACK R3
MDR report key: 11614593
·
Received April 5, 2021
Report
- Report Number
- 9615410-2021-00001
- Event Type
- Death
- Date Received
- April 5, 2021
- Report Date
- March 30, 2021
- Manufacturer
- AMYLIOR INC.
- Product Code
- ITI
- UDI-DI
- 00827482201738
- PMA / PMN Number
- K092225
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
OFFICIAL DATE OF EVENT IS UNKNOWN. REQUEST MADE TO GET THE CHAIR BACK FOR EVALUATION; WE ARE STILL WAITING FOR A RESPONSE. SHOULD THE DEVICE BECOME AVAILABLE OR FURTHER INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
Description of Event or Problem · 1
MR. (B)(6) WAS VISITING THE BEACH; ONE THE CASTERS SHREDDED, HE SLAMMED INTO THE CURB AND THE CHAIR FLIPPED OVER HIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510641 | ALLTRACK R3 | POWER WHEELCHAIR | ITI | AMYLIOR INC. | ALLTRACK R3 | 00827482201738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |