MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for HURRYCANE manufactured by Unknown.
[79594490]
(b)(4) received notification of an incident involving a cane that (b)(4) imports and distributes. The patient allegedly broke their ankle while using the cane. (b)(4) has been provided the wrong phone number and no other contact information; therefore further information could not be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00060 |
| MDR Report Key | 6700290 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-13 |
| Date Facility Aware | 2017-06-13 |
| Report Date | 2017-07-11 |
| Date Reported to FDA | 2017-07-11 |
| Date Added to Maude | 2017-07-11 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HURRYCANE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2017-07-11 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-11 |