MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for HURRYCANE manufactured by Jan Mao Industrial Co., Ltd.
[74445850]
Drive is the initial importer of the device. End-user claims that the cane does not stand on its own as advertised and she has fallen 3 times when trying to pick the device up off the floor. End-user has allegedly injured her right shoulder during one of these incidents and was allegedly told by an orthopedist that she "re-tore her rotator cuff". However, none of the allegations have been confirmed by medical scan. We are awaiting further information from end-user after unrelated heart surgery is to be completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00038 |
| MDR Report Key | 6545799 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-30 |
| Date Facility Aware | 2017-04-03 |
| Report Date | 2017-04-27 |
| Date Reported to Mfgr | 2017-04-27 |
| Date Added to Maude | 2017-05-04 |
| 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 | 2017-05-04 |
| Model Number | HURRYCANE |
| 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,, CHINA 531400 CH 531400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-04 |