FDA Adverse Event
Malfunction
Summary report: N
SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK
MDR report key: 4820706
·
Received June 5, 2015
Report
- Report Number
- 1525712-2015-03304
- Event Type
- Malfunction
- Date Received
- June 5, 2015
- Report Date
- May 12, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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
DEALER STATED LEFT FLIP BACK ARM BRACKET IS BROKEN. DEALER STATED NOT AWARE HOW IT BROKE. DEALER HUNG UP RECEIVED INFORMATION FROM CUSTOMER SERVICE REPRESENTATIVE. PROTOCOL QUESTIONS NOT APPLICABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365261 | SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK | WHEELCHAIR, MECHANICAL | IOR | INVACARE TAYLOR STREET | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |