FDA Adverse Event
Summary report: N
CANES
MDR report key: 3031634
·
Received April 2, 2013
Report
- Report Number
- 1531186-2013-01361
- Date Received
- April 2, 2013
- Report Date
- April 1, 2013
- Manufacturer
- PINGHU WEIFENG MATERIAL TECHNOLOGY
- Product Code
- IPS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - COPY OF MEDWATCH 3500A REPORT INDICATING UF/IMPORTER REPORT #(B)(4) WAS RECEIVED BY INVACARE. MDR BEING FILED BASED ON THE INFORMATION RECEIVED.
Description of Event or Problem · 1
THE END USER STATED THE CANE COLLAPSED ON HER WHEN SHE WAS WALKING ON HER PORCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135115 | CANES | 890.3075 | IPS | PINGHU WEIFENG MATERIAL TECHNOLOGY | 40918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 | Other |