MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; SCOOTER

Model Number	SC40X GO GO ULTRA X 3 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleges she was backing up on a sidewalk and the back wheel went off the sidewalk into the grass allegedly causing the scooter to lean to one side and tip over.
Additional Manufacturer Narrative
The device has not been made available for evaluation.Should further information of the device become available, a follow-up report will be issued.
Additional Manufacturer Narrative
Per tech: the alleged incident was caused by user error.The unit is working properly.
Event or Problem Description
Alleges she was backing up on a sidewalk and the back wheel went off the sidewalk into the grass allegedly causing the scooter to lean to one side and tip over.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: SCOOTER
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 8008008586
• MDR Report Key: 15198298
• Report Number: 2530130-2022-00072
• Device Sequence Number: 13993934
• Product Code: INI
• UDI-Device Identifier: 00606509300223
• UDI-Public: 00606509300223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC40X GO GO ULTRA X 3 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female