FDA.reportPublic FDA data

MAUDE MDR 7995149

MDR report key
7995149
Report number
MW5080752
Event key
0
Event type
3
Date of event
2013-10-07
Date received
2018-10-22
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
1DENTURES FULLDENTURES FULLUNKNSLI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-2201. O

Event Narratives#

D

Patient 1

(B)(6) CONTRACTED TO FABRICATE BAR-RETAINED, IMPLANT-SUPPORTED FULL ARCH UPPER DENTURE. AFTER HE INSISTED ON EXTRACTING REMAINING TEETH LEAVING ME EDENTULOUS, BUT DEFRAUDED ME WITH DENTURE WITH FLAWS. HE DELIBERATELY CREATED AND REFUSED TO CORRECT DESPITE HARM AND TAKING MY MONEY. IMPLANT RETAINED FULL ARCH SCREW-IN UPPER DENTURE FABRICATED FROM ACRYLIC TEETH ON A CARD. HEAVILY PATCHED AREA IS SHARP, CUTS TONGUE, BIG LUMP OF PLASTIC AND FILED AREA IMPAIRS SPEECH, SUCKING ON AREA CAUSES HEADACHES, NECK PAIN, GUM PAIN/INFECTION, OBSTRUCTIVE AIRWAY. (B)(6). REFER TO LETTER TO (B)(6), UNITED STATES FOOD AND DRUG ADMINISTRATION WHICH INCLUDES DOCUMENTATION AND PICTURES. (B)(6) 2018-ON ADVISEMENT INSPECTOR GENERAL US CONSUMER PRODUCT SAFETY COMMISSION.