FDA.reportPublic FDA data

MAUDE MDR 7916384

MDR report key
7916384
Report number
8020994-2018-00001
Event key
0
Event type
3
Date of event
2018-08-24
Date received
2018-09-27
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
MR. PAULO CALLE
Address
1717 W COLLINS AVENUE ORANGE CA 92867 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIFE REGULAR SETLIFE FAST SET, LIFE REGULAR SETKERR ITALIA S.R.L.EJK617696456795R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-2701. O

Event Narratives#

N

Patient 1

IT WAS REPORTED BY THE COMPLAINANT THAT LIFE BASE WAS USED AS A PRESSURE INDICATION PASTE TO IDENTIFY AREAS OF OVER EXTENSION ON AN ACRYLIC DENTURE COMPLAINANT IS AWARE THAT THIS IS NOT THE STANDARD APPLICATION. NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO WEIGHT, ETHNICITY, AND RACE.

D

Patient 1

A COMPLAINANT ALLEGED THAT PATIENT EXPERIENCED THROBBING AND TIGHTNESS PARTICULARLY ON THE LEFT ANTERIOR MAXILLA. PATIENT NOTICED SWELLING OF THE UPPER AND LOWER LIP AS WELL AS TONGUE. PATIENT ALSO HAD A LEFT EAR ACHE. THE PAIN EXTENDED TO THE INFRAORBITAL REGION AND THERE WAS SOME MILD PERIORBITAL SWELLING AS WELL AS WATERING OF THE EYE. THIS CONTINUED TO PROGRESS TO A SORE THROAT. PATIENT WENT TO THE HOSPITAL DUE TO THE CONTINUED SYMPTOMS. PATIENT WAS DIAGNOSED WITH EXPERIENCING AN ALLERGIC REACTION, BUT NO TREATMENT WAS REQUIRED. THE SWELLING STARTED TO REDUCE, HOWEVER THERE ARE TWO AREAS OF ULCERATION PRESENT.