HAWLEY RETAINER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for HAWLEY RETAINER manufactured by Allesee Orthodontic Appliances.

MAUDE Entry Details

Report Number2184045-2019-00004
MDR Report Key9241924
Date Received2019-10-25
Date of Report2019-10-25
Date of Event2019-10-09
Date Mfgr Received2019-10-09
Device Manufacturer Date2019-09-25
Date Added to Maude2019-10-25
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. SUZANNE SIMPKINS
Manufacturer Street13931 SPRING STREET
Manufacturer CitySTURTEVANT WI 53177
Manufacturer CountryUS
Manufacturer Postal53177
Manufacturer Phone2628861050
Manufacturer G1ALLESEE ORTHODONTIC APPLIANCES
Manufacturer Street13931 SPRING STREET
Manufacturer CitySTURTEVANT WI 53177
Manufacturer CountryUS
Manufacturer Postal Code53177
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHAWLEY RETAINER
Generic NameORTHODONTIC RETAINER
Product CodeDYJ
Date Received2019-10-25
Lot Number4714338
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerALLESEE ORTHODONTIC APPLIANCES
Manufacturer Address13931 SPRING STREET STURTEVANT WI 53177 US 53177


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-25

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