PRIDE MOBILITY PRODUCTS LC358M N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-14 for PRIDE MOBILITY PRODUCTS LC358M N/A manufactured by Pride Mobility Products.

Event Text Entries

[144968044] The device has not yet been made available for evaluation. Should further information or the device become available for evaluation, a follow-up report will then be issued.
Patient Sequence No: 1, Text Type: N, H10


[144968045] Alleges hand control started to smoke and user got scared. The fire department had to get user out of the chair.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2530130-2019-00054
MDR Report Key8607684
Report SourceDISTRIBUTOR
Date Received2019-05-14
Date of Report2019-06-28
Date of Event2019-05-08
Date Mfgr Received2019-05-09
Device Manufacturer Date2016-05-10
Date Added to Maude2019-05-14
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 NameELECTRIC POSITIONING CHAIR
Product CodeINO
Date Received2019-05-14
Returned To Mfg2019-05-28
Model NumberLC358M
Catalog NumberN/A
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPRIDE MOBILITY PRODUCTS
Manufacturer Address401 YORK AVE DURYEA PA 18642 US 18642


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.