MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-02 for DRIVE UNKNOWN manufactured by Unknown.
[184254237]
Drive devilbiss is the initial importer of the device which is a knee walker. The end-user rented the device from a service provider. We were notified of the incident by legal representatives of the end-user. We do not ave the device for evaluation. We are filing this report in an overabundance of caution and to be timely. Follow-up reports will be filed when additional data is available. The knee pad broke away from the knee walker rental causing her to fall. She hit her head, fractured her hand, and reportedly sustained other injuries, all of which required her to seek emergency medical care and hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00017 |
| MDR Report Key | 9777461 |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-11-12 |
| Date Facility Aware | 2020-02-23 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Added to Maude | 2020-03-02 |
| 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 | KNEE WALKER |
| Product Code | ITJ |
| Date Received | 2020-03-02 |
| 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 | 2020-03-02 |