MATRX POSTURE SEAT CUSHION W20 X D20 9153650829 ITPCSR

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 2016-06-27 for MATRX POSTURE SEAT CUSHION W20 X D20 9153650829 ITPCSR manufactured by Invacare Cleveland Street.

Event Text Entries

[48298337] A follow up will be sent if the product or additional information is obtained. Mdr is being submitted as a result of a retrospective complaint review.
Patient Sequence No: 1, Text Type: N, H10


[48298338] The hardware on the back broke on one side and stressed on the other.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219590-2016-00111
MDR Report Key5751288
Report SourceDISTRIBUTOR
Date Received2016-06-27
Date of Report2011-11-09
Date Mfgr Received2011-11-09
Date Added to Maude2016-06-27
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 FDA3
Event Location3
Manufacturer ContactKEVIN GUYTON
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVACARE CLEVELAND STREET
Manufacturer Street899 CLEVELAND STREET
Manufacturer CityELYRIA OH 44036
Manufacturer CountryUS
Manufacturer Postal Code44036
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 CodeIMP
Date Received2016-06-27
Model NumberITPCSR
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVACARE CLEVELAND STREET
Manufacturer Address899 CLEVELAND STREET ELYRIA OH 44036 US 44036


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-27

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