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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 S6102 VICTORY 10.2 3 WHEEL
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Abrasion (1689); Bruise/Contusion (1754)
Date of Event 08/04/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should the device or further information become available, a follow-up report will then be issued.
 
Event or Problem Description
Alleges renting scooter and as customer was leaving hotel room, customer scraped up against an ac unit causing injury to leg.
 
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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 Key12331414
Report Number2530130-2021-00088
Device Sequence Number14631019
Product Code INI
UDI-Device Identifier00606509300469
UDI-Public00606509300469
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K072165
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) 08/17/2021
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 NumberS6102 VICTORY 10.2 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 08/16/2021
Initial Report FDA Received Date08/17/2021
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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