WHEELCHAIR COMPONENTS AHL4A_PTO_19911

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 2014-05-19 for WHEELCHAIR COMPONENTS AHL4A_PTO_19911 manufactured by Invamex.

Event Text Entries

[4499464] Provider states the upper support assembly is broken where the leg rest support tube assembly and the shoulder screw meet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616091-2014-00882
MDR Report Key3818865
Report Source08
Date Received2014-05-19
Date of Report2014-04-04
Date Mfgr Received2014-04-04
Date Added to Maude2014-06-26
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 ContactGREGORY STEVENS
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVAMEX
Manufacturer StreetPARQUE INDUSTRIAL MANIMEX
Manufacturer CityREYNOSA 88780
Manufacturer CountryMX
Manufacturer Postal Code88780
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWHEELCHAIR COMPONENTS
Generic Name890.3920
Product CodeKNN
Date Received2014-05-19
Model NumberAHL4A_PTO_19911
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVAMEX
Manufacturer AddressPARQUE INDUSTRIAL MANIMEX REYNOSA 88780 MX 88780


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-05-19

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