BEDS BY GEORGE 3500

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 2019-09-04 for BEDS BY GEORGE 3500 manufactured by Beds By George, Inc..

MAUDE Entry Details

Report Number3008830652-2019-00004
MDR Report Key8962215
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-09-04
Date of Report2019-09-04
Date of Event2018-06-19
Date Mfgr Received2018-06-19
Device Manufacturer Date2017-08-30
Date Added to Maude2019-09-04
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. ADAM DAVIS
Manufacturer Street1045 N. NAPPANEE ST.
Manufacturer CityELKHART IN 46514
Manufacturer CountryUS
Manufacturer Postal46514
Manufacturer Phone5743332310
Manufacturer G1BEDS BY GEORGE, INC.
Manufacturer Street109 14TH AVE S BUILDING 2
Manufacturer CityMIDDLEBURY IN 46540
Manufacturer CountryUS
Manufacturer Postal Code46540
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBEDS BY GEORGE
Generic NameHAVEN
Product CodeOYS
Date Received2019-09-04
Model Number3500
Catalog Number3500
Lot NumberSOMOZA 041217
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBEDS BY GEORGE, INC.
Manufacturer Address1045 N. NAPPANEE ST. ELKHART IN 46514 US 46514


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-04

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