MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for DRIVE UNKNOWN manufactured by Unknown.
[123671416]
(b)(4) is the initial importer of the device which is a power mobility device. The customer could not provide serial number or model number. We are filing this report in an overabundance of caution. End-user was ascending on a ramp to enter into a drug store when the scooter reported tilted to the side. It fell over. The fall caused her to dislocate her shoulder. She was brought to the hospital where she remained for (3) three days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00053 |
| MDR Report Key | 7962450 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-09-14 |
| Date Facility Aware | 2018-09-14 |
| Report Date | 2018-10-12 |
| Date Reported to FDA | 2018-10-12 |
| Date Added to Maude | 2018-10-12 |
| 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 | POWER MOBILITY DEVICE |
| Product Code | INI |
| Date Received | 2018-10-12 |
| Model Number | UNKNOWN |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-12 |