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

Model Number	S73 GO GO SPORT 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	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Consumer alleges she was charging her batteries when she was allegedly noticed a burning smell.
Additional Manufacturer Narrative
An fst replaced charger and battery box.Provided demo on how to use unit and assemble/dissemble for transport.Unit is working properly.
Event or Problem Description
Consumer alleges she was charging her batteries when she was allegedly noticed a burning smell.

• 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: 11990866
• Report Number: 2530130-2021-00060
• Device Sequence Number: 3214961
• Product Code: INI
• UDI-Device Identifier: 00606509300209
• UDI-Public: 00606509300209
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062160
• 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): 08/05/2021

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: S73 GO GO SPORT 3 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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: Other