HERBST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-15 for HERBST manufactured by Allesee Orthodontic Appliances.

Event Text Entries

[20229181] The customer stated that upper portion of the herbst is causing sores.
Patient Sequence No: 1, Text Type: D, B5


[20537180] The patient was prescribed chlorhexidine, an antiseptic rinse, for treatment. The doctor's office stated that the new appliance will not be placed at the moment. The patient's parents will decide whether the appliance should be placed or not, after meeting with the doctor. To date, the patient is doing fine. The appliance was not returned, therefore, no evaluation of the appliance could be conducted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2184045-2012-00004
MDR Report Key2493333
Report Source05
Date Received2012-03-15
Date of Report2012-02-14
Date Mfgr Received2012-02-14
Device Manufacturer Date2011-09-30
Date Added to Maude2012-03-16
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 FDA0
Event Location0
Manufacturer ContactMR. ORLANDO TADEO, JR.
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167419
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 Report3

Device Details

Brand NameHERBST
Generic NameBITE-JUMPING ORTHODONTIC APPLIANCE
Product CodeEJF
Date Received2012-03-15
ID NumberWORK ORDER #3439124
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLESEE ORTHODONTIC APPLIANCES
Manufacturer Address13931 SPRING STREET STURTEVANT WI 53177 US 53177


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-03-15

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