FDA.reportPublic FDA data

MAUDE MDR 1639131

MDR report key
1639131
Report number
MW5015268
Event key
0
Event type
3
Date received
2010-03-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NOT AVAILABLEDENTURESAFFORDABLE DENTURESNSL Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-03-2001. O

Event Narratives#

D

Patient 1

AFFORDABLE DENTURES MISFITTED ME WITH TEMPORARY DENTURES, EVEN AFTER I TOLD THEM I ONLY WANTED ONE SET OF DENTURES, NOT TWO. AFTER REPEATED APPOINTMENTS, THEY DID NOT MAKE THE DENTURES FUNCTIONAL. I COULD BARELY EAT SOUP, WITHOUT PAIN. THEY NEVER INFORMED ME, THAT THESE WERE TEMPORARY DENTURES. I ONLY FOUND THIS OUT, WHEN I WENT TO A NEW DENTIST. REFUSED TO MAKE RIGHT. I NOW HAVE HIGHLY FUNCTIONAL DENTURES. I CAN EAT ANYTHING, INCLUDING POPCORN, APPLES, NUTS, CANDY, 'CORN ON THE COB', AND NOTHING SEEMS UNEATABLE. ALL, WITHOUT ANY GELS OR ADHESIVES. AFFORDABLE DENTURES SENT ME AN ADVERTISEMENT, FOR DENTURE ANCHORS. IF THEY WOULD MAKE DECENT DENTURES, THERE WOULD BE NO NEED FOR ANCHORS, OR, TWO SETS OF DENTURES. I HAVE HAD DENTURES FOR OVER 50 YEARS. UNTIL NOW, NEVER A TEMPORARY DENTURE. DIAGNOSIS OR REASON FOR USE: EATING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.