MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-16 for DRIVE manufactured by .
[64889949]
(b)(4) received notification of an incident involving a cane that (b)(4) distributes. On two occasions, the enduser was using the cane in her home when allegedly, one of the feet detached causing her to fall onto her face. The patient sustained a bruised right eye and medical attention was not sought. The item has not been returned therefore no further evaluation has been conducted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00002 |
| MDR Report Key | 6254020 |
| Date Received | 2017-01-16 |
| Date of Report | 2016-12-19 |
| Date Facility Aware | 2016-12-19 |
| Report Date | 2017-01-16 |
| Date Reported to FDA | 2017-01-16 |
| Date Added to Maude | 2017-01-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2017-01-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-16 |