WHEELCHAIR ACCESSORY 9042

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 2013-07-03 for WHEELCHAIR ACCESSORY 9042 manufactured by New Prokin.

Event Text Entries

[3582126] Provider states seam is fraying on sling.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1531186-2013-02996
MDR Report Key3206435
Report Source*
Date Received2013-07-03
Date of Report2013-06-13
Date of Event2013-06-11
Date Facility Aware2013-06-13
Report Date2013-07-03
Date Reported to FDA2013-07-03
Date Reported to Mfgr2013-07-03
Date Added to Maude2013-07-03
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 FDA3
Event Location0
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWHEELCHAIR ACCESSORY
Generic Name890.3910
Product CodeINE
Date Received2013-07-03
Model Number9042
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNEW PROKIN
Manufacturer AddressZHONGSHAN CH


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-07-03

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