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

Model Number	SC609 VICTORY 9 3 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2021
Type of Reportable Event	Serious Injury
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's daughter alleges, her mother's rental chair hit her and kept going allegedly pinning her to a wall and still kept going.It allegedly knocked her down and ended up on top of her.
Event or Problem Description
Provider alleges, consumer's daughter alleges, her mother's rental chair hit her and kept going allegedly pinning her to a wall and still kept going.It allegedly knocked her down and ended up on top of her.
Additional Manufacturer Narrative
Provider states their tech did a full evaluation of the unit and found no issues.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE-WHEEL VEHICLE
• MDR Report Key: 12698463
• Report Number: 2530130-2021-00117
• Device Sequence Number: 3856245
• Product Code: INI
• UDI-Device Identifier: 00606509300377
• UDI-Public: 00606509300377
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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?: Yes
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other