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 2018-09-20 for PRIDE MOBILITY PRODUCTS UNKNOWN N/A manufactured by Pride Mobility Products.

Event Text Entries

[120904306] The exact "date of death" was not provided. The "model #", "serial #" and "device manufacture date" have not been provided. 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.
Patient Sequence No: 1, Text Type: N, H10


[120904307] It is alleged that at some point during a car ride from the hospital back home, her scooter she was sitting on tipped over and fell with her in it causing her injury.
Patient Sequence No: 1, Text Type: D, B5


[134607701] Pride is not a party in the suit. No further information received.
Patient Sequence No: 1, Text Type: N, H10


[134607702] It is alleged that at some point during a car ride from the hospital back home, her scooter she was sitting on tipped over and fell with her in it causing her injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2530130-2018-00126
MDR Report Key7895125
Report SourceOTHER
Date Received2018-09-20
Date of Report2019-01-28
Date Mfgr Received2018-09-03
Date Added to Maude2018-09-20
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 Received2018-09-20
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. Death 2018-09-20

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