MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for HURRYCANE HURRYCANE GO CANE HCANE-BK-G2 manufactured by Unknown.
[139607894]
(b)(4) is the initial importer of the device which is a cane. The cane was discarded because it was broken. No examination and root cause analysis can be performed. The cane was provided to the end-user in an assisted living facility. He fell when the cane bent. It is believed that the push button malfunctioned. He was hurt and hospitalized. The patient broke his right hip in the fall. He is 6 foot 2 inches. He requested a rollator instead of a cane replacement because he believed the cane was unsuitable for his age.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00008 |
| MDR Report Key | 8445261 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-21 |
| Date of Event | 2018-04-01 |
| Date Facility Aware | 2019-03-05 |
| Report Date | 2019-03-21 |
| Date Reported to FDA | 2019-03-21 |
| Date Added to Maude | 2019-03-22 |
| 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 | 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 | HURRYCANE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2019-03-22 |
| Model Number | HURRYCANE GO CANE |
| Catalog Number | HCANE-BK-G2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-22 |