MAUDE MDR 7743105

MDR report key
7743105
Report number
MW5078826
Event key
0
Event type
3
Date of event
2018-12-25
Date received
2018-08-01
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
1RETAINER BRITERETAINER, SCREW EXPANSION, ORTHODONTICDENTSPLY SIRONA ORTHODONTICS INC.DYJI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-0101. L; 2. R; 3. S

Event Narratives#

D

Patient 1

FOR TWO YEARS I LOST THE ABILITY TO DIGEST FOOD WELL. ABOUT EVERY OTHER B. M WAS THE RUNS. I LOST SIGNIFICANT WEIGHT AND HAD SEVERE DEHYDRATION. THE PROBLEM RESOLVED AFTER ENDING INVISALIGN RETAINER AND RETAINER BRITE CLEANER. I SWITCHED TO AN ACRYLIC AND METAL RETAINER AND BAKING SODA AND VINEGAR CLEANING. MY DIGESTION IMPROVED EXCEPT FOR A SEVERE REACTION TO DAIRY. DURING THIS ILLNESS I DEVELOPED ARTHRITIS. I ASKED MY DENTIST WHAT THE RETAINER WAS MADE OF. HE SAID THEY ARE MADE IN MEXICO AND COULD NOT TELL ME BECAUSE IT WAS PROPRIETARY. I PAID (B)(6) FOR CORE AND TESTING IN ADDITION TO WHAT MY INSURANCE PAID. THE ONLY RELIEF WAS I.V.'S. THE DRS AND SPECIALISTS HAD NO EXPLANATION. I TRIED THE RETAINER ON MY OWN INITIATIVE BASED ON THE FACT I BROKE OUT IN FACIAL SWEAT WHEN I ATE FOOD. AN MRI SHOWED HIP ARTHRITIS THAT EXPLAINED THE PAIN THAT STARTED DURING THIS ILLNESS. INVISALIGN - DENTAL RETAINER; RETAINER BRITE - RETAINER CLEANER; 1 TAB/NIGHT, 1 / DAY, I TABLET IN WATER WITH RETAINER OVERNIGHT. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2015; DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2017. "DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: YES; DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: DIDN'T RESTART."