FDA.reportPublic FDA data

MAUDE MDR 7911947

MDR report key
7911947
Report number
2424472-2018-00150
Event key
0
Event type
3
Date received
2018-09-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KARL NITTINGER
Address
221 W. PHILADELPHIA ST. SUITE 60W YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COM-FIT SUPER HIGH FILTRATION MASKS EAR LOOP BLUEMASK, SURGICALDENTSPLY LLCFXXNA0020326FGD687203261/1814122601097Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-2601. O

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.