BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARA

    MDR report key: 1630809 · Received March 8, 2010

    Report

    Report Number
    MW5015108
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 8, 2010
    Manufacturer
    JOHNS DENTAL LABORATORIES
    Product Code
    EJF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON WAS WEARING A METAL DENTAL EXPANDER IN HIS MOUTH CALLED A MARA. IT IS MANUFACTURED BY JOHNS DENTAL LABORATORIES IN (B) (4). HE WOKE TO FIND THAT A PIECE OF STEEL HAD BROKEN OFF. HE SWALLOWED THE PIECE IN HIS SLEEP. WE ARE VERY CONCERNED THAT OTHER CHILDREN WHO HAVE MARAS COULD HAVE THIS HAPPEN TO THEM. THEY CAN CHOKE. WE X-RAYED OUR SON'S STOMACH THAT DAY. THE PIECE OF MARA WAS THERE. THE PEDIATRICIAN AND RADIOLOGIST DETERMINED THAT ALTHOUGH THIS OBJECT WAS SHARP, IT WAS TOO RISKY TO INDUCE VOMIT BECAUSE IT COULD LODGE IN THE ESOPHAGUS ON THE WAY UP. THE DETERMINATION WAS TO LET IT PASS THROUGH THE BOWELS WHICH IT DID 5 DAYS LATER. THE DAY AFTER THE EVENT, WE TOOK OUR SON TO THE ORTHODONTIST TO HAVE THE REMAINDER OF THE MARA REMOVED. WE COULDN'T FATHOM THE RISK OF ANY FURTHER BREAKAGE. THE ORTHODONTIST AT THE TIME STATED THAT HE KNEW THE BRACKETS TEND TO FALL OFF AND THAT IS WHY HE "DOUBLE WIRES' THEM ON. THIS IS A SERIOUS ISSUE IN AND OF ITSELF. HOWEVER, IN OUR CASE, THE METAL ACTUALLY BROKE AND WAS SWALLOWED. THE BRACKET DIDN'T FALL OFF, IT WAS SHEARED. DATES OF USE: ABOUT 1-2 YEARS. DIAGNOSIS OR REASON FOR USE: JAW EXPANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARA JAW EXPANDER EJF JOHNS DENTAL LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Disability