MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for DRIVE MEDICAL HURRYCANE manufactured by Jan Mao Industries Co., Ltd..
[87760435]
Drive medical has received a complaint from the patient's husband on an incident allegedly involving a cane imported and distributed by (b)(4). It was reported that the patient was using the cane during a vacation in (b)(6) when the cane was allegedly buckled causing her to fall and hit her head. The patient went to hospital and allegedly had plastic surgery and 60 stitches on her head. This mdr report is based on the information provided by the claimant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00022 |
| MDR Report Key | 6903643 |
| Date Received | 2017-09-29 |
| Date of Report | 2016-04-08 |
| Date of Event | 2015-12-01 |
| Date Facility Aware | 2016-04-08 |
| Report Date | 2016-05-06 |
| Date Reported to FDA | 2016-05-06 |
| Date Reported to Mfgr | 2016-05-06 |
| Date Added to Maude | 2017-09-29 |
| 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 | DRIVE MEDICAL |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2017-09-29 |
| 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 INDUSTRIES 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 | 2017-09-29 |