MAUDE MDR 4730572

MDR report key
4730572
Report number
MW5042316
Event key
0
Event type
3
Date of event
2015-03-09
Date received
2015-04-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
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
1LIBERTY SPORT - LIBERTY SS2000 CHILDRENS EYEGLASSES TEMPLE PINNONEHQZ

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-200

Event Narratives#

D

Patient 1

MY SON IS (B)(6) YEARS OLD AND HAS A CONDITION CALLED CEREBRAL PALSY. BECAUSE OF HIS CEREBRAL PALSY, HE FALLS EASILY. HE ALSO REQUIRES GLASSES. I WOULD LIKE TO REPORT LIBERTY SPORT GLASSES WITH AN PROTRUDING TEMPLE PIN AS A SAFETY HAZARD. MY SON HAS FALLEN TWO TIMES IN THE PAST MONTH. ON BOTH OCCASIONS, HE HAS FALLEN ONTO HIS RIGHT SIDE, WHILE WEARING HIS GLASSES AND THE TEMPLE PIN HAS PENETRATED HIS TEMPLE. ALSO ON BOTH OCCASIONS, HE HAS REQUIRED STITCHES. THE FIRST INCIDENCE OCCURRED ON (B)(6) AND THE SECOND ON (B)(6). THE LACERATIONS WERE IN THE SAME GENERAL AREA BUT NOT THE EXACT SPOT. THE FIRST TIME IT OCCURRED, I THOUGHT THAT IT WAS JUST A FREAK ACCIDENT. BUT AFTER OCCURRING AGAIN, I THOUGHT THAT SOMETHING MUST BE DONE TO MAKE THE GLASSES SAFER. IT WAS A VERY TRAUMATIC EVENT AND I AM CONCERNED FOR THE SAFETY OF OTHER CHILDREN. THE COMPANY THAT MANUFACTURES THE EYEGLASSES IS LIBERTY SPORT. OUR PARTICULAR STYLE WAS CALLED THE LIBERTY SS2000 AND THE HAZARD IN THE TEMPLE PIN. (B)(4).