WHEELCHAIR ACCESSORY 7740P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2013-07-19 for WHEELCHAIR ACCESSORY 7740P manufactured by Foshan R. Poon Medical Products Co., Ltd..

Event Text Entries

[63753835] Per importer's mdr: mdr decision date: (b)(6) 2013. No serious injury alleged. Malfunction alleged. Ivc territory business manager states where the top of the vertical portion fit into the upper, the slot has expanded, making the trapeze wobbly. Mdr filed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000282279-2013-00098
MDR Report Key6210624
Report SourceDISTRIBUTOR
Date Received2013-07-19
Date of Report2013-07-18
Date Mfgr Received2013-06-29
Date Added to Maude2016-12-28
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 G1FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
Manufacturer StreetNEW CITY DISTRICT, DANZAO
Manufacturer CityNANHAI, FOSHAN 528216
Manufacturer CountryCH
Manufacturer Postal Code528216
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWHEELCHAIR ACCESSORY
Generic NameWHEELCHAIR ACCESSORY
Product CodeKNO
Date Received2013-07-19
Model Number7740P
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
Manufacturer AddressNEW CITY DISTRICT, DANZAO NANHAI, FOSHAN 528216 CH 528216


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-07-19

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