MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for HURRYCANE HCANE-BL-C2 manufactured by Jan Mao Industrial Co., Ltd.
[117419870]
(b)(4) is the initial importer of the device which is a hurrycane branded cane. End-user reported that the handle of the cane broke off as he was descending the stairs. He broke his wrist and bruised his neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00043 |
| MDR Report Key | 7791609 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-08-16 |
| Report Date | 2018-08-16 |
| Date Reported to FDA | 2018-08-16 |
| Date Reported to Mfgr | 2018-08-19 |
| Date Added to Maude | 2018-08-16 |
| 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 |
| 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 | 2018-08-16 |
| Model Number | HCANE-BL-C2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAO INDUSTRIAL CO., LTD |
| Manufacturer Address | PINGGUO COUNTY INDUSTRIAL ZONE BAISE CITY GUANGXI, 531400 CH 531400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-16 |