MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for DRIVE 10216BL-1 manufactured by Unknown.
[177397082]
Drive devilbiss healthcare is the initial importer of the device which is a bariatric rollator. The unit has not been returned for evaluation. End-user was injured when the rollator slid out from under him while he sat on its seat. The brakes reportedly failed to work while engaged. He suffered an l2 vertebrae compression fracture requiring surgical repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00006 |
| MDR Report Key | 9643217 |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-09-14 |
| Date Facility Aware | 2019-12-09 |
| Report Date | 2020-01-29 |
| Date Reported to FDA | 2020-01-29 |
| Date Added to Maude | 2020-01-29 |
| 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 | BARIATRIC ROLLATOR |
| Product Code | ITJ |
| Date Received | 2020-01-29 |
| Model Number | 10216BL-1 |
| 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 | 2020-01-29 |