HERBST

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 2016-05-03 for HERBST manufactured by Herbst.

Event Text Entries

[44278764] Specific patient information such as weight was not provided. The patient experienced that the herbst device had encroached upon the soft tissues and caused oral lesions on the patients cheeks. The doctor removed appliance and recommended that the patient rinse with chlorhexidine. To date the patient is doing fine; however, scar tissue is now present.
Patient Sequence No: 1, Text Type: N, H10


[44278765] Doctor alleged that patient experienced severe trauma to the cheeks.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2184045-2016-00001
MDR Report Key5624655
Report SourceOTHER
Date Received2016-05-03
Date of Report2016-04-14
Date Mfgr Received2016-04-14
Device Manufacturer Date2016-02-15
Date Added to Maude2016-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. MARY LAMBERT
Manufacturer Street13931 SPRING STREET
Manufacturer CitySTURTEVANT WI 53177
Manufacturer CountryUS
Manufacturer Postal53177
Manufacturer Phone2623213670
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHERBST
Generic NameBITE-JUMPING ORTHODONTIC APPLIANCE
Product CodeEJF
Date Received2016-05-03
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHERBST
Manufacturer AddressALLESEE ORTHODONTIC APPLIANCES 13931 SPRING STREET STURTEVANT WI 53177 US 53177


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-05-03

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