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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE
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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE Back to Search Results
Model Number SC44E GO GO ELITE TRAVELLER 4 WHEEL
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 01/31/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The user was hit by a car while in the device.Not an issue with the product.
 
Event or Problem Description
Provider alleges the consumer was hit by a car while crossing the street.
 
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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 Key11308670
Report Number2530130-2021-00015
Device Sequence Number11083575
Product Code INI
UDI-Device Identifier00606509300100
UDI-Public00606509300100
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K063389
Number of Events Summarized1
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
Report Date (Section B) 02/10/2021
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 NumberSC44E GO GO ELITE TRAVELLER 4 WHEEL
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2021
Initial Report FDA Received Date02/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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