MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE

Model Number	SC609 VICTORY 9 3 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Consumer alleges he turned onto a lawn and the unit allegedly flipped over on him.
Additional Manufacturer Narrative
The consumer has since passed away (unrelated to alleged incident).The family no longer has the device.Therefore, the device is not available for evaluation.
Event or Problem Description
Consumer alleges he turned onto a lawn and the unit allegedly flipped over on him.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 10593696
• Report Number: 2530130-2020-00088
• Device Sequence Number: 1192454
• Product Code: INI
• UDI-Device Identifier: 00606509300377
• UDI-Public: 00606509300377
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: SC609 VICTORY 9 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: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: Hospitalization