BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOGEN CIRCUMCISION CLAMP

    MDR report key: 81119 · Received April 1, 1997

    Report

    Report Number
    2431021-1997-90001
    Event Type
    Other
    Date Received
    April 1, 1997
    Date of Event
    February 18, 1997
    Report Date
    March 12, 1997
    Manufacturer
    MILTEX INSTRUMENT CO.
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A ROUTINE CIRCUMCISION ON A ONE DAY OLD INFANT, EXTRA SKIN FROM THE MUCUS MEMBRANE OF THE PENIS SEPARATED. THE PHYSICIAN CALLED IN A UROLOGIST WHO SUBSEQUENTLY STITICHED THE SEPARATION. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. THE PRIMARY PHYSICIAN FOLLOWED UP WITH THE UROLOGIST, NO ADDITIONAL TREATMENT IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOGEN CIRCUMCISION CLAMP SURGICAL DEVICE HFX MILTEX INSTRUMENT CO. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention