MAUDE Adverse Event Report: LERADO ZHONGSHAN DRIVE; 3 WHEEL MOBILITY

Model Number	SF1320-CF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a 3 wheeled power scooter.The unit was returned to the selling agent and is unavailable for investigation.The customer states that her husband was on the item going slowly the day he received it.He was turning in the driveway when the item tilted.He put his foot down to catch the fall.He was taken to the hospital where they took x-rays which reportedly showed a minimal fracture in his hip.At the time of this report the end-user was in rehab with no prospect of surgery.He also is reported to have suffered "brush burns" on his arm and some scabs on his hand from stopping the unit from tipping.

• Brand Name: DRIVE
• Common Device Name: 3 WHEEL MOBILITY
• Manufacturer (Section D): LERADO ZHONGSHAN; 26 guangfu road; dong sheng town; zhong shan, duangdong 52841 4; CH 528414
• MDR Report Key: 7751786
• Report Number: 2438477-2018-00039
• Device Sequence Number: 11247397
• Product Code: INI
• UDI-Device Identifier: 00822383984025
• UDI-Public: 822383984025
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2018
• Report Date (Section F): 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SF1320-CF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/29/2018
• Event Location: Home
• Date Report to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 72
• Date Report Sent to FDA: 08/03/2018