FDA Adverse Event
Malfunction
Summary report: N
SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK
MDR report key: 4861424
·
Received June 23, 2015
Report
- Report Number
- 9616091-2015-01611
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Report Date
- June 16, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(6) 2015 - SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
THE TBM ALSO STATES ON THE RIGHT SIDE WHEEL LOCK THAT ENGAGES THE WHEEL, ISN'T HOLDING. HE STATES THE PROVIDER ALLEGED THIS IS A CONSISTENT ISSUE WITH THIS BRAKE AND HE HAS TO TIGHTEN IT OFTEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406696 | SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |