ADJUSTABLE HERBST SLEEP APPLIANCE 00566

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-10-24 for ADJUSTABLE HERBST SLEEP APPLIANCE 00566 manufactured by Dynaflex.

MAUDE Entry Details

Report Number0001937100-2019-00005
MDR Report Key9234256
Report SourceOTHER
Date Received2019-10-24
Date of Report2019-09-24
Date of Event2019-04-01
Date Mfgr Received2019-04-01
Device Manufacturer Date2017-05-22
Date Added to Maude2019-10-24
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 ContactMS MAUREEN MILLER
Manufacturer Street10403 INTL PLAZA DRIVE
Manufacturer CityST. ANN MO 63074
Manufacturer CountryUS
Manufacturer Postal63074
Manufacturer Phone3144264020
Manufacturer G1DYNAFLEX
Manufacturer Street10403 INTL PLAZA DRIVE
Manufacturer CityST. ANN MO 63074
Manufacturer CountryUS
Manufacturer Postal Code63074
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADJUSTABLE HERBST SLEEP APPLIANCE
Generic NameADJUSTABLE HERBST
Product CodeLRK
Date Received2019-10-24
Model Number00566
Catalog Number00566
Lot Number661938
Device Expiration Date2018-05-22
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDYNAFLEX
Manufacturer Address10403 INTL PLAZA DRIVE ST. ANN MO 63074 US 63074


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2019-10-24

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