FDA Adverse Event
Malfunction
Summary report: N
TRANSPORT 20 IN X 16 IN 9153637574
MDR report key: 4973551
·
Received August 5, 2015
Report
- Report Number
- 1525712-2015-04169
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Report Date
- July 14, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
THE CONSUMER STATES THE BACK BRACKET ON THE BACK CANES HAS BROKEN. WE NO LONGER HAVE PARTS FOR THIS CHAIR, SO ARE UNABLE TO REPLACE THE PART. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517360 | TRANSPORT 20 IN X 16 IN 9153637574 | WHEELCHAIR, MECHANICAL | IOR | INVACARE TAYLOR STREET | AX3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |