CAREX FGB65877 0000 B658-77

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-24 for CAREX FGB65877 0000 B658-77 manufactured by Aid-pro Healthcare Co., Ltd.

MAUDE Entry Details

Report Number3012316249-2019-00026
MDR Report Key9111823
Date Received2019-09-24
Date of Report2019-09-24
Date of Event2019-09-03
Date Facility Aware2019-09-04
Report Date2019-09-24
Date Reported to FDA2019-09-24
Date Reported to Mfgr2019-09-24
Date Added to Maude2019-09-24
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAREX
Generic NameBATH & SHOWER SEAT WITH BACK
Product CodeILS
Date Received2019-09-24
Model NumberFGB65877 0000
Catalog NumberB658-77
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAID-PRO HEALTHCARE CO., LTD
Manufacturer AddressNO. 58 YU LONG 3 ROAD DONG SHENG TOWN ZHONG SHAN CITY GUANGDONG, CH


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-24

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