FDA Adverse Event
Injury
Summary report: N
TILITE AERO Z
MDR report key: 13053182
·
Received December 21, 2021
Report
- Report Number
- 3032618-2021-00010
- Event Type
- Injury
- Date Received
- December 21, 2021
- Date of Event
- November 1, 2021
- Report Date
- December 21, 2021
- Manufacturer
- TISPORT, LLC
- Product Code
- IOR
- PMA / PMN Number
- K990358
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE CUSTOMER ALLEGES THAT THE WHEEL LOCK WAS BROKEN AND DIDN'T LOCK HIS TIRES. THE END USER WAS REPORTED INJURED WHILE TRANSFERRING FROM AERO Z CHAIR TO VEHICLE. LIMITED INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING THE EXACT NATURE OF THE INJURY. A REVIEW OF THE DHR INDICATES THAT THE WHEELCHAIR PASSED ALL APPLICABLE QUALITY TESTS AND REQUIREMENTS, AND MET ALL SPECIFICATIONS AS ORDERED BY DEALER WHEN IT WAS SERIALIZED ON (B)(6) 2017, AND LEFT THE FACILITY (B)(6) 2017.
Description of Event or Problem · 0
USER STATES THAT HANDLE TO WHEEL LOCK BROKE WHEN HE WAS ATTEMPTING TRANSFER. HE INJURED HIMSELF AND IS REQUESTING BILLS BE PAID FROM HIS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1950316 | TILITE AERO Z | MANUAL WHEELCHAIR, PRODUCT CODE: IOR | IOR | TISPORT, LLC | AERO Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Hospitalization |