CAREX WEIGHT CAPACITY 300 LB SHOWER STOOL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-20 for CAREX WEIGHT CAPACITY 300 LB SHOWER STOOL manufactured by Com-da Healthcare Co., Ltd..

MAUDE Entry Details

Report Number3014644996-2019-00001
MDR Report Key8810001
Date Received2019-07-20
Date of Report2019-07-20
Date of Event2019-07-01
Date Mfgr Received2019-07-19
Date Added to Maude2019-07-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactKEVIN WALLS
Manufacturer Street33 GOLDEN EAGLE LANE
Manufacturer CityLITTLETON CO 80127
Manufacturer CountryUS
Manufacturer Postal80127
Manufacturer Phone7209625412
Manufacturer G1COM-DA HEALTHCARE CO., LTD.
Manufacturer StreetUNIT 3 NO. 94 DONGCHENG ROAD DONG SHENG TOWN
Manufacturer CityZHONG SHAN CITY, GUANGDONG
Manufacturer CountryCH
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAREX WEIGHT CAPACITY 300 LB SHOWER STOOL
Generic NameHYGIENE ADAPTOR
Product CodeILS
Date Received2019-07-20
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOM-DA HEALTHCARE CO., LTD.
Manufacturer AddressUNIT 3 NO. 94 DONGCHENG ROAD DONG SHENG TOWN ZHONG SHAN CITY, GUANGDONG CH


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-20

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