SURESMILE ALIGNER PATIENT KIT ORX00004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-31 for SURESMILE ALIGNER PATIENT KIT ORX00004 manufactured by Dentsply Sirona Orthodontics Inc..

Event Text Entries

[125686803] While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


[125686804] It was reported that a patient experienced an allergic reaction after using the suresmile aligner patient kit. The reported symptoms include swollen lips, swollen gingiva, numb tongue and difficulty breathing. The patient went to the emergency room for treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1036212-2018-00006
MDR Report Key8024742
Report SourceHEALTH PROFESSIONAL
Date Received2018-10-31
Date of Report2018-11-29
Date of Event2018-09-26
Date Mfgr Received2018-11-06
Date Added to Maude2018-10-31
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 ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1DENTSPLY SIRONA ORTHODONTICS INC.
Manufacturer Street7290 26TH COURT EAST
Manufacturer CitySARASOTA FL 34243
Manufacturer CountryUS
Manufacturer Postal Code34243
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURESMILE ALIGNER PATIENT KIT
Generic NameDENTAL PROPHYLAXIS KIT
Product CodeNYC
Date Received2018-10-31
Returned To Mfg2018-11-06
Model NumberNA
Catalog NumberORX00004
Lot NumberSO-000002641403
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY SIRONA ORTHODONTICS INC.
Manufacturer Address7290 26TH COURT EAST SARASOTA FL 34243 US 34243


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-10-31

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