FDA.reportPublic FDA data

MAUDE MDR 3963455

MDR report key
3963455
Report number
MW5037451
Event key
0
Event type
3
Date received
2014-07-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
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
1RETAINERRETAINERRAINTREE ESSEXJEP Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-2401. H; 2. L; 3. O; 4. S

Event Narratives#

D

Patient 1

LIPS HAD BLISTERS, PEELED, PUFFED THREE MONTHS, BIG BOILS ON LIPS NON STOP. WENT EMERGENCY ROOM THEY DIDN'T KNOW WHAT TO DO. DATES OF USE: SUMMER 2007 - (B)(6). DIAGNOSIS OR REASON FOR USE: RETAINER - HOLDING TEETH IN PLACE. EVENT ABATED AFTER USE STOPPED OR DOSAGE REDUCED: YES.