MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-20 for DRIVE R726BL manufactured by Hebei Healthplus Medical Device Co Ltd.
[176298792]
Drive devilbiss is the initial importer of the device which is a rollator. The device has not been returned for evaluation. End-user was tired and went to sit on the rollator. It was reportedly locked but moved t from under him. He fell on his left arm and hit his head. He sustained a concussion from the fall. He reportedly has tears between the incoustal space of his ribs on his left side. He suffered abrasions on his lower leg where he hit the concrete. He went to the hospital the same day. He is currently on bed rest. He is already being treated at a pain clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00004 |
| MDR Report Key | 9607308 |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-12-19 |
| Date Facility Aware | 2019-12-20 |
| Report Date | 2020-01-20 |
| Date Reported to FDA | 2020-01-20 |
| Date Reported to Mfgr | 2020-01-20 |
| Date Added to Maude | 2020-01-20 |
| 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 | ROLLATOR |
| Product Code | ITJ |
| Date Received | 2020-01-20 |
| Model Number | R726BL |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD |
| Manufacturer Address | 1, CHUANGYE ST SW INDUSTRIAL MATOU ECOLOGICAL INDUSTRY PARK HANDAN CITY HEBEI,, 056046 CH 056046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-20 |