WHEELCHAIR COMPONENTS RP176013

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-04-11 for WHEELCHAIR COMPONENTS RP176013 manufactured by Maxhealth Corp..

Event Text Entries

[20329144] Per provider the foot rest is broke at the weld.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1531186-2014-01290
MDR Report Key3743966
Report Source*
Date Received2014-04-11
Date of Report2014-03-11
Date Facility Aware2014-03-11
Report Date2014-04-10
Date Reported to FDA2014-04-10
Date Reported to Mfgr2014-04-10
Date Added to Maude2014-04-11
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 Location0
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWHEELCHAIR COMPONENTS
Generic Name890.3920
Product CodeKNN
Date Received2014-04-11
Model NumberRP176013
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMAXHEALTH CORP.
Manufacturer Address15F-6 NO. 81, HSIN TAI WU RD SECTION 1 HSI CHIH, TAIPEI HSIEN TW


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-04-11

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