MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for DRIVE R800RD manufactured by Unknown.
[184253358]
Drive devilbiss healthcare is the initial importer of the device which is a rollator. The device has not been retrieved for inspection. We are filing this report in an overabundance of caution. Reportedly the rollator brake control cables failed while in use causing the end-user to fall to the floor. The injuries sustained were addressed by surgical means.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00014 |
| MDR Report Key | 9729887 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-12 |
| Date Facility Aware | 2020-01-30 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| 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 | R800RD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |