SEAT GV/SB/VW20/VD20/VAH 9153648882 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-24 for SEAT GV/SB/VW20/VD20/VAH 9153648882 UNKNOWN manufactured by Unknown.

Event Text Entries

[26845952] Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10


[26845953] Provider states that the right easy mount bracket broke while the patient was in the chair. Per provider, the wheelchair is made by quickie and has an invacare back.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525712-2015-04625
MDR Report Key5099805
Date Received2015-09-24
Date of Report2015-08-26
Date Mfgr Received2015-08-26
Date Added to Maude2015-09-24
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 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 Report0

Device Details

Brand NameSEAT GV/SB/VW20/VD20/VAH 9153648882
Generic NameCUSHION, WHEELCHAIR
Product CodeIMP
Date Received2015-09-24
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 2015-09-24

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