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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 SC54 GO GO ELITE TRAVELLER PLUS 4 WHEEL
Medical Device Problem Code Fire (1245)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The "date of event" and "patient identifier" have not been provided.The device has not yet been made available for evaluation.Should the device become available or further information be received, a follow-up report will then be issued.
 
Event or Problem Description
Alleges device caught on fire.
 
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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 Key11279057
Report Number2530130-2021-00013
Device Sequence Number4117277
Product Code INI
UDI-Device Identifier00606509300131
UDI-Public00606509300131
Combination Product (Y/N)N
Initial Reporter StateDC
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) 02/02/2021
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 NumberSC54 GO GO ELITE TRAVELLER PLUS 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 02/02/2021
Initial Report FDA Received Date02/04/2021
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 Other;
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