MAUDE Adverse Event Report: DONGGUAN PRESTIGE SPORTING GOODS CO LTD 3RD INDUST DRIVE MEDICAL; SCOOTER

Model Number	FLEX-AUTOACC-RD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Limb Pain (4836)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a scooter by an end user, who stated that the scooter fell onto her while driving down a ramp.The end user is undergoing therapy for injuries to her wrist shoulder and ankle that were sustained during the incident.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Common Device Name: SCOOTER
• Manufacturer (Section D): DONGGUAN PRESTIGE SPORTING GOODS CO LTD 3RD INDUST; 3rd industry district, qiaotou; houjie town; dongguan, guangdong 52395 0; CH 523950
• MDR Report Key: 15986647
• Report Number: 2438477-2022-00123
• Device Sequence Number: 12190069
• Product Code: INI
• UDI-Device Identifier: 00822383975733
• UDI-Public: 822383975733
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2022
• Report Date (Section F): 12/15/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: FLEX-AUTOACC-RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/06/2022
• Device Age: 2 YR
• Date Report to Manufacturer: 12/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 12/15/2022