FDA.reportPublic FDA data

MAUDE MDR 5765807

MDR report key
5765807
Report number
9612352-2016-00002
Event key
0
Event type
3
Date of event
2016-06-01
Date received
2016-07-01
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
MS. DONNA HARTNETT
Address
175 PINEVIEW DR. AMHERST NY 14228 US
Phone
716-716-7166
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IPS EMPRESS CADPORCELAIN/POWDERIVOCLAR VIVADENT AGEIH602568R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-0101. R

Event Narratives#

N

Patient 1

INGESTION OF FOREIGN OBJECTS CAN OCCUR AT ANY TIME DURING DENTAL PROCEDURES. ONCE A FOREIGN OBJECT HAS REACHED THE STOMACH IT IS EXPECTED THAT IT WILL PASS THROUGH THE GASTROINTESTINAL TRACT AS A RESULT OF PERISTALSIS MOVEMENT WITHOUT COMPLICATION, USUALLY AFTER A 7-10 DAY PERIOD. FOLLOW UP WITH PATIENT ON (B)(6) 2016 INDICATED IMPROVEMENT AND PILL CAMERA PROCEDURE REVEALED EVIDENCE OF HEALING. PATIENT REPORTS CT SCANS, COLONOSCOPY AND ENDOSCOPY PROCEDURES CONDUCTED WITH NO EVIDENCE OF BROKEN TOOTH PIECE FOUND.

D

Patient 1

PATIENT SWALLOWED PORTION OF IPS EMPRESS CAD CROWN THAT HAD BEEN PLACED ON TOOTH #18 BY THE DENTIST ON (B)(6) 2013. PATIENT RETURNED TO DENTIST ON (B)(6) 2016 INDICATING THAT A PIECE OF THE CROWN WAS SWALLOWED AFTER EATING ALMONDS. THE DOCTOR CONFIRMED THAT A PORTION OF THE PATIENTS CROWN FRACTURED ON THE DISTOLINGUAL CUSP. ON (B)(6) 2016 THE PATIENT RETURNED TO THE OFFICE CLAIMING THE PORTION OF THE CROWN SWALLOWED CAUSED PAIN AND DAMAGE TO HIS DIGESTIVE SYSTEM.