MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-07-26 for LUGGIE SCOOTER manufactured by Freerider, Corp..
[3625166]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10911162]
The user has not returned the luggie scooter to the dealer nor the importer for further evaluation. We're not able to get to know the scooter's condition at this stage. After receiving the scooter's serial number from the importer, we'll conduct the relevant tests.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003820676-2013-00002 |
| MDR Report Key | 3267273 |
| Report Source | 08 |
| Date Received | 2013-07-26 |
| Date Mfgr Received | 2013-07-26 |
| Date Added to Maude | 2013-08-09 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | NO. 22, BENGONG 5TH RD. |
| Manufacturer City | GANGSHAN DIST., KAOHSIUNG CITY 820 |
| Manufacturer Country | TW |
| Manufacturer Postal | 820 |
| Manufacturer Phone | 76223093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUGGIE SCOOTER |
| Generic Name | LUGGIE SCOOTER |
| Product Code | KNL |
| Date Received | 2013-07-26 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREERIDER, CORP. |
| Manufacturer Address | NO. 22, BENGONG 5TH RD. GANGSHAN DIST., KAOSIUNG CITY 820 TW 820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-26 |