MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for DRIVE 790 manufactured by Unknown.
[178335632]
Drive devilbis healthcare is the initial importer of the device which is a knee walker. The unit has not been recovered for evaluation. End-user was recovering from left ankle achilles surgery. He is a "tall, big guy". On the second day the device slid out from under the user. He fell and landed on his right leg, he was diagnosed with a fractured/dislocated my ankle and broke tibia which required surgery. Patient was treated in a nursing home for 4 months. Handle height on product is 3. 0875 feet. Product is discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00009 |
| MDR Report Key | 9673461 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Facility Aware | 2020-02-05 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Model Number | 790 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |