MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for SCOOTER 86498 manufactured by Unk.
[101145693]
Reporter states that she was delivered a scooter at her home yesterday (b)(6) 2018 and it is not working. According to reporter, the scooter would not charge despite the fact that it was plugged all night. She also mentioned that the scooter was emitting a very strong smell that was disturbing to her. Reporter is requesting for a new scooter as soon as possible. Reporter was able to provide the name of the distributor (b)(4) but did not have the name of the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075523 |
| MDR Report Key | 7295990 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-22 |
| Date Added to Maude | 2018-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | SCOOTER |
| Generic Name | SCOOTER |
| Product Code | KNL |
| Date Received | 2018-02-23 |
| Model Number | 86498 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |