MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for DRIVE GV974HD-BR manufactured by Chang Cheng Fa Enterprise Co., Limited9.
[184252614]
Drive devilbiss healthcare is the initial importer of the device which is a rollator. The device has not been returned for evaluation. The end user sat on the device. The rear left wheel of the product reportedly detached and he fell backwards he was unconscious for about 20 minutes. He ended up being diagnosed with a fractured t7 vertebra. A procedure called a kyphoplasty was recommended but he elected not to undergo surgery at this time and is instead just treating with pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00011 |
| MDR Report Key | 9728741 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-11-05 |
| Date Facility Aware | 2002-02-19 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-02-20 |
| Date Added to Maude | 2020-02-19 |
| 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 | 2020-02-19 |
| Model Number | GV974HD-BR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHANG CHENG FA ENTERPRISE CO., LIMITED9 |
| Manufacturer Address | NO. 1 BEEN TING, BEEN-TSUOH VI CHIA-YI SHIANN SHI-KOOU SHIANG, CHIAYI - DISTRICT TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |