FDA Adverse Event
Malfunction
Summary report: N
MAGIC MOBILITY
MDR report key: 7644597
·
Received June 28, 2018
Report
- Report Number
- 3003650116-2018-00062
- Event Type
- Malfunction
- Date Received
- June 28, 2018
- Date of Event
- June 7, 2018
- Report Date
- June 28, 2018
- Manufacturer
- MAGIC MOBILITY
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CLIENT REPORTED THAT THERE WAS A LOOSE WHEEL NUT. CHAIR WAS LESS THAN ONE MONTH OLD. CLIENT WAS NOT INJURED. WHEEL DID NOT COME OFF. THE WHEEL AREA WAS MAKING AN UNUSUAL NOISE AND THIS ALERTED THE CLIENT. CLIENT TIGHTENED WHEEL NUT. MAGIC SENT REPLACEMENT TO ENSURE THAT THERE THE NUT WAS IN AS NEW CONDITION. CLIENT HAS NOT REPORTED ANY FURTHER PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490848 | MAGIC MOBILITY | EXTREME X8 | ITI | MAGIC MOBILITY | X8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |