MAUDE MDR 6800987

MDR report key
6800987
Report number
MW5071648
Event key
0
Event type
3
Date of event
2017-08-01
Date received
2017-08-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DENTURESDENTURESNSLI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-140

Event Narratives#

D

Patient 1

CONSUMER IS (B)(6) AND IT WAS TIME FOR A NEW SET OF DENTURES. SHE WENT TO (B)(6) WHICH IS ALL PROFESSORS THAT PRACTICE IN AN OFFICE. DR. (B)(6) WAS THE DENTIST THAT TREATED HER. ON TUESDAY (B)(6), SHE GOT FITTED FOR DENTURES AND WAS TOLD THEY ARE LIKE BREAKING IN A NEW PAIR OF SHOES. BY THE TIME SHE GOT HOME AT THE END OF THE 8 HOURS, HER MOUTH WAS BURNING. SHE THOUGHT IT WAS STRANGE BUT THOUGHT SHE WAS JUST GETTING ADJUSTED TO IT. THE NEXT DAY AFTER SHE TOOK THEM OUT HER MOUTH WAS SWOLLEN. THE THIRD DAY, HER MOUTH WAS BLISTERED, RAW AND SWOLLEN. WHEN SHE WENT BACK THE FOLLOWING TUESDAY THE DENTIST LOOKED AT HER MOUTH. THE DENTURES ARE MADE FROM A NEW MATERIAL AND SHE WAS TOLD THEY GIVE OFF GASES/MONOMERS AND THERE ARE SOME PEOPLE THAT ARE ALLERGIC TO THOSE MONOMERS. THE DENTIST CALLS FOR A MEDICAL CONSULT. THE DOCTOR SAID HE WAS GOING TO GIVE HER A STEROID RINSE FOR HER MOUTH. SHE TOLD HIM THAT SHE'S IMMUNOCOMPROMISED AND CAN'T TAKE STEROIDS.