BARI10A BARIATRIC BED BARI10ABED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-10 for BARI10A BARIATRIC BED BARI10ABED manufactured by Joerns Healthcare.

MAUDE Entry Details

Report Number3009402404-2019-00059
MDR Report Key8982874
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-09-10
Date of Report2019-09-10
Date of Event2019-08-19
Date Mfgr Received2019-08-21
Date Added to Maude2019-09-10
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 ContactFELICIA BANKS
Manufacturer Street2100 DESIGN ROAD
Manufacturer CityARLINGTON TX 76014
Manufacturer CountryUS
Manufacturer Postal76014
Manufacturer Phone8008260270
Manufacturer G1JOERNS HEALTHCARE
Manufacturer StreetAVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL
Manufacturer CityMATAMOROS, 87499
Manufacturer CountryMX
Manufacturer Postal Code87499
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBARI10A BARIATRIC BED
Generic NameBARIATRIC BED
Product CodeOSI
Date Received2019-09-10
Model NumberBARI10ABED
Catalog NumberBARI10ABED
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerJOERNS HEALTHCARE
Manufacturer AddressAVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL MATAMOROS, 87499 MX 87499


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-09-10

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