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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 S710LXW VICTORY LX SPORT
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/13/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation as of yet.Should further information or the device become available, a follow-up report will then be completed.
 
Event or Problem Description
Provider alleges consumer was reaching for something on the shelf when she was allegedly thrown to the floor on her back.
 
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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 Key9670506
Report Number2530130-2020-00019
Device Sequence Number16243520
Product Code INI
UDI-Device Identifier00606509300360
UDI-Public00606509300360
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K071949
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) 02/05/2020
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 NumberS710LXW VICTORY LX SPORT
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 01/31/2020
Initial Report FDA Received Date02/05/2020
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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