FREERIDER LUG5ABLJBBAAA1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for FREERIDER LUG5ABLJBBAAA1 manufactured by Freerider Corp..

Event Text Entries

[136003254] (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. (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. (b)(6) 2019: importer received this report on jan. /25/2019.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008786141-2019-00001
• MDR Report Key: 8334586
• Date Received: 2019-02-13
• Date of Report: 2018-06-12
• Date of Event: 2018-05-10
• Device Manufacturer Date: 2017-05-18
• Date Added to Maude: 2019-02-13
• 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: MR. JASON HUANG
• Manufacturer Street: NO.22, BENGONG 5TH RD. GANGSHAN DIST.
• Manufacturer City: KAOHSIUNG, TAIWAN 820
• Manufacturer Country: TW
• Manufacturer Postal: 820
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FREERIDER
• Generic Name: LUGGIE SUPER
• Product Code: INI
• Date Received: 2019-02-13
• Model Number: LUG5ABLJBBAAA1
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FREERIDER CORP.
• Manufacturer Address: NO.22, BENGONG 5TH RD. GANGSHAN DIST. KAOHSIUNG, TAIWAN 820 TW 820

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-02-13