CUSHION RIGIDIZER 16 IN X 16 IN 9153653337 CUSTOMMANUAL

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 2015-01-14 for CUSHION RIGIDIZER 16 IN X 16 IN 9153653337 CUSTOMMANUAL manufactured by Unknown.

Event Text Entries

[18025380] It was reported by dealer that the rigidizer has cracked in half.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525712-2015-00329
MDR Report Key4417112
Report Source08
Date Received2015-01-14
Date of Report2014-12-31
Date Mfgr Received2014-12-31
Date Added to Maude2015-02-03
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 NameCUSHION RIGIDIZER 16 IN X 16 IN 9153653337
Generic NameCUSHION, WHEELCHAIR
Product CodeIMP
Date Received2015-01-14
Model NumberCUSTOMMANUAL
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 2015-01-14

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