MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for DRIVE 790 manufactured by Hl Corp.
[176298578]
Drive devilbiss healthcare is the initial importer of the device which is a knee walker. We have not received the device for evaluation. The end-user was utilizing the device throughout his recuperation from achilles tendon surgery. He was walking in the park aided by the knee walker when the right hand brake snapped. He fell to the pavement and reinjured his achilles tendon on his left side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00003 |
| MDR Report Key | 9603850 |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2018-06-25 |
| Date Facility Aware | 2019-12-23 |
| Report Date | 2020-01-17 |
| Date Reported to FDA | 2020-01-17 |
| Date Reported to Mfgr | 2020-01-17 |
| Date Added to Maude | 2020-01-17 |
| 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 | 2020-01-17 |
| Model Number | 790 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HL CORP |
| Manufacturer Address | THE 3RD INDUSTRIAL PARK BITOU VILLAGE, SONG GANG TOWN BAOAN DISTRICT, SHENZHEN, GUANGDONG 518105 CH 518105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-17 |