MAUDE MDR 1058369

MDR report key
1058369
Report number
MW5007227
Event key
0
Event type
3
Date received
2008-06-05
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FLENTS KID'S SILICONE EAR PLUGSSILICONE EAR PLUGSAPOTHECARY PRODUCTS, INC.EWDC265N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-06-050

Event Narratives#

D

Patient 1

FATHER PUT EAR PLUGS IN EARS OF AN AUTISTIC AND BLIND CHILD FOR BATH ON INSTRUCTIONS OF DOCTOR DUE TO RECENT ADENOIDECTOMY. THIS HAD BEEN PROCEDURE FOR PAST 2 MONTHS. THIS LAST TIME WAS USING THE FIRST USAGE OF THE LAST PAIR OF EAR PLUGS IN THE PACKAGE. AFTER BATH THE CHILD WOULD TAKE THE PLUGS OUT AND HAND THEM TO THE DAD WHO WOULD PUT THEM ASIDE FOR NEXT USAGE. IN 2008, THE RIGHT EAR PLUG CAME APART AND A GOOD PORTION OF THE PLUG REMAINED IN THE EAR CANAL. MOTHER TRIED TO REMOVE IT WITH TWEEZERS, BUT THE PLUG CAME APART IN TINY PIECES, SO WE TOOK CHILD TO EMERGENCY ROOM WHERE AFTER 90 MINUTES OF HORROR THE PLUG WAS FINALLY REMOVED BY THE ER DOCTOR. PHOTOS ENCLOSED SHOWING THE TINY PARTICLES WHICH WERE REMOVED FROM CHILD'S EAR. DOCTOR REMARKED THAT THE PLUG HAD THE CONSISTENCY OF CHEESE. THIS CAUSED MUCH PAIN FOR THE CHILD AND CONCERN FOR THE PARENTS. DOCTOR PRESCRIBED ANTIBIOTIC EAR DROPS THE NEXT FEW DAYS FOR CHILD AND MAKE APPOINTMENT WITH ENT DOCTOR SOON AS POSSIBLE. THE NEXT DAY, FATHER CALLED THE COMPANY TO LET THEM KNOW EVENT. SPOKE TO PERSON WHO WANTED SAMPLE OF PLUG SENT TO COMPANY. COPY OF THIS REPORT INCLUDED WITH SAMPLE.