PRIDE MOBILITY PRODUCTS UNKNOWN N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-10-17 for PRIDE MOBILITY PRODUCTS UNKNOWN N/A manufactured by Pride Mobility Products.

Event Text Entries

[123994815] Pride (b)(4) states the contact information provided is not valid. The device has not been made available for evaluation at this time. Should the device or further information become available, a follow-up report will then be issued.
Patient Sequence No: 1, Text Type: N, H10


[123994816] Alleges putting on charge at 5:00pm and left charge overnight. At 5:30am, neighbor noticed smoke coming out of garage. Alleges product burst in flames while charging.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2530130-2018-00146
MDR Report Key7973961
Report SourceOTHER
Date Received2018-10-17
Date of Report2018-10-16
Date of Event2018-05-30
Date Mfgr Received2018-10-12
Date Added to Maude2018-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMISS KELLY LIVINGSTON
Manufacturer Street401 YORK AVE
Manufacturer CityDURYEA PA 18642
Manufacturer CountryUS
Manufacturer Postal18642
Manufacturer Phone5706024056
Manufacturer G1N/A
Manufacturer StreetN/A N/A
Manufacturer CityN/A
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRIDE MOBILITY PRODUCTS
Generic NameMOTORIZED THREE-WHEELED VEHICLE
Product CodeINI
Date Received2018-10-17
Model NumberUNKNOWN
Catalog NumberN/A
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPRIDE MOBILITY PRODUCTS
Manufacturer Address401 YORK AVE DURYEA PA 18642 US 18642


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-17

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