MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-01-24 for FREERIDER LUG5ABLJBBAAA1 manufactured by Freerider Corp..
[134102459]
On (b)(6) 2018: mrs. (b)(6) was driving the scooter up a slope, and then she drop down curb. It caused her right arm, wrist, thumb and hand injured. On (b)(6) 2018: mrs. (b)(6) claimed to (b)(4) distributor about this accident event, and thought the scooter is faulty because she had fallen off twice. Once coming up a curb and once pushing it up the drive. On 01/22/2019: manufacturer received this report on jan. /22/2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003820676-2019-00001 |
| MDR Report Key | 8276735 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-01-24 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2019-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VIVIAN YEH |
| Manufacturer Street | NO.22, BENGONG 5TH RD. GANGSHAN DIST. |
| Manufacturer City | KAOHSIUNG, TAIWAN 820 |
| Manufacturer Country | TW |
| Manufacturer Postal | 820 |
| Manufacturer G1 | JASON HUANG |
| Manufacturer Street | NO.22, BENGONG 5TH RD. GANGSHAN DIST. |
| Manufacturer City | KAOHSIUNG, TAIWAN |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREERIDER |
| Generic Name | LUGGIE SUPER |
| Product Code | INI |
| Date Received | 2019-01-24 |
| Model Number | LUG5ABLJBBAAA1 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREERIDER CORP. |
| Manufacturer Address | NO.22, BENGONG 5TH RD. GANGSHAN DIST. KAOHSIUNG CITY, TAIWAN 820 TW 820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-24 |