WHEELCHAIR ACCESSORY 9070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-13 for WHEELCHAIR ACCESSORY 9070 manufactured by H Fine And Son Ltd.

Event Text Entries

[63704344] Per importer's mdr: mdr decision date: 01/10/2013. On 01/15/2013 - seh: no serious injury alleged. Malfunction alleged. The dealer stated the straps are ripping on one side. Mdr filed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004859134-2013-00003
MDR Report Key6206515
Date Received2013-06-13
Date of Report2013-06-13
Date Mfgr Received2013-06-06
Date Added to Maude2016-12-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KEVIN WALLS
Manufacturer Street33 GOLDEN EAGLE LANE
Manufacturer CityLITTLETON CO 80127
Manufacturer CountryUS
Manufacturer Postal80127
Manufacturer Phone7209625412
Manufacturer G1H FINE AND SON LTD.
Manufacturer Street93 MANOR FARM RD.
Manufacturer CityWEMBLEY, MIDDLESEX HAO 1XB
Manufacturer CountryUK
Manufacturer Postal CodeHAO 1XB
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWHEELCHAIR ACCESSORY
Generic NameWHEELCHAIR ACCESSORY
Product CodeKNO
Date Received2013-06-13
Model Number9070
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerH FINE AND SON LTD
Manufacturer Address93 MANOR FARM RD. WEMBLEY, MIDDLESEX HAO 1XB UK HAO 1XB


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-06-13

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