MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE WHEEL

Model Number	SC710 VICTORY 10 4 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Provider alleges consumer alleges his scooter was on his car carrier to go to his clinic.Once there, the scooter allegedly rolled off the carrier and allegedly ran over his toe.Consumer turned allegedly trying to catch his scooter and allegedly injured his hip.
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.
Event or Problem Description
Provider alleges consumer alleges his scooter was on his car carrier to go to his clinic.Once there, the scooter allegedly rolled off the carrier and allegedly ran over his toe.Consumer turned allegedly trying to catch his scooter and allegedly injured his hip.
Additional Manufacturer Narrative
The unit freewheeled while in drive upon return.This was due to the brake handle being severely bent to the point it's throw was impeded by the rear motor cover.(customer misuse) when the cover was removed, the handle was able to reach the full engaged position and the unit functioned as designed.The unit's regenerative braking system functioned as design.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE WHEEL
• 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: 15417558
• Report Number: 2530130-2022-00076
• Device Sequence Number: 12443021
• Product Code: INO
• UDI-Device Identifier: 00606509300346
• UDI-Public: 00606509300346
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071949
• 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): 09/27/2022

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: SC710 VICTORY 10 4 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2021
• 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: Male