MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for DRIVE 10210-4ASM manufactured by Zhongshan Bliss Medical.
[177396737]
Drive deviilbiss healthcare is the initial importer of the device which is a walker. The device has not been recovered for evaluation. While using the walker the leg broke off. The end-user fell and his head reportedly went through a wall. He went to the emergency room. He is scheduled for a brain scan this week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00007 |
| MDR Report Key | 9643480 |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-08 |
| Date Facility Aware | 2020-01-29 |
| Report Date | 2020-01-29 |
| Date Reported to FDA | 2020-01-29 |
| Date Reported to Mfgr | 2020-01-30 |
| Date Added to Maude | 2020-01-29 |
| 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 |
| Generic Name | WALKER |
| Product Code | ITJ |
| Date Received | 2020-01-29 |
| Model Number | 10210-4ASM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHONGSHAN BLISS MEDICAL |
| Manufacturer Address | 98, ZHAOYI ROAD, DONGSHENG TOWN ZHONGSHAN CITY,, 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-29 |