MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for DRIVE UNKNOWN manufactured by Unknown.
[184252533]
Drive devilbiss healthcare is the initial importer of the device which is reportedly a rollator. No model number has been provided nor has the unit been returned for evaluation. This report is being tendered in an overabundance of caution. It will be updated with a follow-up should additional data become available. The device 's left gear went out and was repaired. Once repaired a sharp metal protruded from the leg. The gear went out again and the brake was replaced. Four days later the incident happened. End-user exited the shower, grabbed the handle of the rollator, and fell to the floor. The rollator hit her face causing an injury under right eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00012 |
| MDR Report Key | 9729319 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-23 |
| Date Facility Aware | 2020-01-23 |
| 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 | UNKNOWN |
| 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. Hospitalization | 2020-02-19 |