MATRX POSTURE SEAT CUSHION W20 X D20 9153650829 MA1818-VI

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 2015-01-07 for MATRX POSTURE SEAT CUSHION W20 X D20 9153650829 MA1818-VI manufactured by Unknown.

Event Text Entries

[5303759] Dealer states this cushion has lost its positioning shape or elements. The cushion is not pressure mapping good per dealer so the patient is not able to use cushion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525712-2015-00052
MDR Report Key4390194
Report Source08
Date Received2015-01-07
Date of Report2014-12-15
Date Mfgr Received2014-12-15
Date Added to Maude2015-01-22
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 ContactKEVIN GUYTON
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44036
Manufacturer CountryUS
Manufacturer Postal44036
Manufacturer Phone8003336900
Manufacturer G1UNKNOWN
Manufacturer CityOH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMATRX POSTURE SEAT CUSHION W20 X D20 9153650829
Generic NameCUSHION, WHEELCHAIR
Product CodeKNO
Date Received2015-01-07
Model NumberMA1818-VI
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 2015-01-07

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