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

Model Number	S50LX GO GO LX 3 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.If the device or further information becomes available, a follow-up report will then be issued.
Event or Problem Description
Alleges scooter seized on customer and it will not operate or roll in free wheel.Police officers had to carry scooter back to her home.
Additional Manufacturer Narrative
Only the transaxle was returned for evaluation.The bearing on the output shaft side seized which prevented the axle from turning.The freewheel did work but only on the brake side of the transaxle.There was no indication from the provider that the consumer was injured or sought medical attention as a result of the failure.Only that the police department carried her scooter to her residence.
Event or Problem Description
Alleges scooter seized on customer and it will not operate or roll in free wheel.Police officers had to carry scooter back to her home.

• 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: 8137119
• Report Number: 2530130-2018-00173
• Device Sequence Number: 1746045
• Product Code: INI
• UDI-Device Identifier: 00606509300186
• UDI-Public: 00606509300186
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K090524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: S50LX GO GO LX 3 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 12/22/2018
• 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