BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO CIRCUMCISION CLAMP

    MDR report key: 4232156 · Received October 27, 2014

    Report

    Report Number
    1125236-2014-00001
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 27, 2014
    Manufacturer
    M.M DENTAL CORP.
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2: BRAND NAME: GOMCO CIRCUMCISION CLAMP, LOT # 120/100613/GC1.3CM.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED INDICATING THAT DURING THE USAGE OF THE DEVICE, THE BELL WAS PULLED THROUGH THE BASE HOLE CREATING CUTS ON THE INFANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681119 GOMCO CIRCUMCISION CLAMP CIRCUMCISION CLAMP HFX M.M DENTAL CORP. 1.3CM 1200/650/GC1.S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other