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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 SC610 VICTORY 10 3 WHEEL
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Injury (2348)
Date of Event 11/27/2019
Type of Reportable Event Serious Injury
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
Alleges consumer exited hotel and was using the sidewalk to cross the street.When reaching end of sidewalk, the consumer allegedly continued to drive unaware the curb ended, drove off the curb, and landed on his side.Alleges daughter tried to catch him and was also injured and damage was caused to the scooter.
 
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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 Key9446025
Report Number2530130-2019-00137
Device Sequence Number2055656
Product Code INI
UDI-Device Identifier00606509300339
UDI-Public00606509300339
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K072165
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/09/2019
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 NumberSC610 VICTORY 10 3 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 12/06/2019
Initial Report FDA Received Date12/10/2019
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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