INVACARE MATRX PB 14X12 9153644946 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-07-05 for INVACARE MATRX PB 14X12 9153644946 UNKNOWN manufactured by Unknown.

Event Text Entries

[48774260] A follow up will be sent if the product or additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10


[48774261] The end user stated that the backrest on his chair attaches with black clips and one of the clips broke on the backrest.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525712-2016-02407
MDR Report Key5768644
Report SourceCONSUMER
Date Received2016-07-05
Date of Report2016-06-06
Date Mfgr Received2016-06-06
Date Added to Maude2016-07-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
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 G1UNKNOWN
Manufacturer CityOH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVACARE MATRX PB 14X12 9153644946
Generic NameCUSHION, WHEELCHAIR
Product CodeIMP
Date Received2016-07-05
Model NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN
Manufacturer AddressOH US


Patients

Patient NumberTreatmentOutcomeDate
10 2016-07-05

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