WHEELCHAIR ACCESSORY T94HC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-07-03 for WHEELCHAIR ACCESSORY T94HC manufactured by Unknown.

Event Text Entries

[3581117] The provider reported the right t94hc footplate cracked in half while the patient was positioning herself in the wheelchair.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525712-2013-05341
MDR Report Key3206338
Report Source08
Date Received2013-07-03
Date of Report2013-06-11
Date Mfgr Received2013-06-11
Date Added to Maude2013-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactPATRICIA MEDINA
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1UNKNOWN
Manufacturer CityOH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWHEELCHAIR ACCESSORY
Generic Name890.3910
Product CodeINE
Date Received2013-07-03
Model NumberT94HC
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN
Manufacturer AddressOH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-07-03

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