MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)

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 2010-03-03 for MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) manufactured by Allesee Orthodontic Appliances.

Event Text Entries

[21427514] On february 4, 2010, a doctor reported that a patient developed severe mouth sores due to irritation from wearing the mara appliance and needed to take antibiotics for infection.
Patient Sequence No: 1, Text Type: D, B5


[21433030] Since each appliance is custom made to the request of the prescription there was no product problem. The doctor has requested that a new appliance be fabricated of a different design for the patient's comfort. The product was irritating the patient's cheek, causing severe sores and an infection. The doctor prescribed antibiotics to treat the infection. The patient is doing fine and will be fitted with the new appliance. This is the final report. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2184045-2010-00001
MDR Report Key1621490
Report Source05
Date Received2010-03-03
Date of Report2010-02-04
Date Mfgr Received2010-02-04
Device Manufacturer Date2009-11-13
Date Added to Maude2010-03-04
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 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 NameMANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)
Generic NamePOSITIONER, TOOTH, PREFORMED
Product CodeKMY
Date Received2010-03-03
ID NumberWO3045921/3094404
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 2010-03-03

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