INVACARE MATRX PB BACK 16 W X 12 H 9153644848 MPB1612

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 2015-02-19 for INVACARE MATRX PB BACK 16 W X 12 H 9153644848 MPB1612 manufactured by Invacare Cleveland Street.

Event Text Entries

[5493943] Dealer states that there are stress cracks around the back where the hardware attaches.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219590-2015-00043
MDR Report Key4526440
Report Source08
Date Received2015-02-19
Date of Report2015-02-11
Date Mfgr Received2015-02-11
Date Added to Maude2015-03-24
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 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 NameINVACARE MATRX PB BACK 16 W X 12 H 9153644848
Generic NameCUSHION, WHEELCHAIR
Product CodeIMP
Date Received2015-02-19
Model NumberMPB1612
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
101. Other 2015-02-19

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