INSPIRE ICE 746-4300

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 2015-03-13 for INSPIRE ICE 746-4300 manufactured by Ormco Corporation.

Event Text Entries

[5470837] A doctor's office alleged that eight (8) patients had experienced mucosa damage after wearing the inspire ice bracket. This is the fourth of eight (8) reports.
Patient Sequence No: 1, Text Type: D, B5


[12975993] Specific patient information with regard to gender, age and weight was not provided. The patient was prescribed pain medication and medication for the mucosa. To date, the patient has fully recovered and is doing fine. The device involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2016150-2015-00007
MDR Report Key4600763
Report Source05
Date Received2015-03-13
Date of Report2015-02-16
Date Mfgr Received2015-02-16
Date Added to Maude2015-03-13
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 FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 WEST COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
Manufacturer G1ORMCO CORPORATION
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINSPIRE ICE
Generic NameORTHODONTIC BRACKET
Product CodeECQ
Date Received2015-03-13
Catalog Number746-4300
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORMCO CORPORATION
Manufacturer Address1332 SOUTH LONE HILLS AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2015-03-13

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