FDA Adverse Event
Malfunction
Summary report: N
9XT SWINGAWAY FRAME STYLE 9153629153
MDR report key: 4890569
·
Received July 6, 2015
Report
- Report Number
- 9616091-2015-01744
- Event Type
- Malfunction
- Date Received
- July 6, 2015
- Report Date
- June 9, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem · 1
CUSTOMER STATES, ONE OF THE BOLTS FOR THE SEAT UPHOLSTERY SHEARED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435508 | 9XT SWINGAWAY FRAME STYLE 9153629153 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |