COM-FIT SUPER HIGH FILTRATION MASKS EAR LOOP BLUE 0020326FG

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 2018-09-26 for COM-FIT SUPER HIGH FILTRATION MASKS EAR LOOP BLUE 0020326FG manufactured by Dentsply Llc.

Event Text Entries

[121845504] 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 is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[121845505] While using a comfit super high filtration mask earloop blue, a dental assistant developed a rash. The assistant had never wore these type of masks before and it is not known what was normally worn. The rash was wherever the mask was sitting. As soon as they stopped wearing the mask, the rash cleared. No medical attention was required and no injury was reported from the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2424472-2018-00150
MDR Report Key7911947
Report SourceHEALTH PROFESSIONAL
Date Received2018-09-26
Date of Report2018-11-08
Date Mfgr Received2018-10-09
Date Added to Maude2018-09-26
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 G1PRESTIGE AMERITECH
Manufacturer Street7201 IRON HORSE BLVD.
Manufacturer CityNORTH RICHLAND HILLS TX 76180
Manufacturer CountryUS
Manufacturer Postal Code76180
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOM-FIT SUPER HIGH FILTRATION MASKS EAR LOOP BLUE
Generic NameMASK, SURGICAL
Product CodeFXX
Date Received2018-09-26
Returned To Mfg2018-09-17
Model NumberNA
Catalog Number0020326FG
Lot NumberD687203261/1814122601097
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY LLC
Manufacturer Address1301 SMILE WAY YORK PA 17404 US 17404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-09-26

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