FDA.reportPublic FDA data

MAUDE MDR 3450023

MDR report key
3450023
Report number
1925223-2013-00155
Event key
0
Event type
3
Date received
2013-10-30
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#

Address
4315 SOUTH LAFAYETTE BLVD. SOUTH BEND IN 46614 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MONDIAL 6ELM DENTURE, PLASTIC, TEETHHERAEUS KULZER GMBHELMBL2 / L31566801038* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-300

Event Narratives#

D

Patient 1

LAB REP CALLED AND SAID THAT THE COMPLETE REMOVABLE DENTURE WAS DELIVERED ON (B)(6) 2012. SHE SAID THAT IT WAS A LOWER ANTERIOR TOOTH. SHE DID NOT KNOW WHICH TOOTH, MOLD OR SHADE IT WAS, BUT SAID SHE WOULD ASK THE LAB GUYS. SHE SAID THAT SHE DOES NOT THINK THE PT SWALLOWED ANY OF THE TOOTH AND WOULD CHECK TO SEE IF THEY HAVE THE FRAGMENTS. SHE SAID THE PT WAS VERY ANGRY THAT SHE HAD TO PAY FOR THE REPAIR. SHE SAID THAT THEY BELIEVE THE PT WAS EATING AND BIT INTO SOMETHING VERY HARD. SHE DID NOT KNOW THE PT'S AGE. ON (B)(6) 2013 LAB REP CALLED AND GAVE THE MOULD AND SHADE. SHE SAID THAT TOOTH NUMBER 24 BROKE. THEY DO NOT HAVE THE BROKEN OFF PART AND THE PART THAT REMAINED IN THE DENTURE WAS DESTROYED TO REMOVE. REF MFR 3006610834-2013-00017.