BEUDAMED
    FDA Adverse Event Other Summary report: N

    1059020-2013-00007

    MDR report key: 3110479 · Received May 13, 2013

    Report

    Report Number
    1059020-2013-00007
    Event Type
    Other
    Date Received
    May 13, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 11, 2013
    PMA / PMN Number
    K921822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT REPORTED AFTER NOTIFICATION OF RECALL OF PUNCHES DUE TO LACK OF STERILIZATION VALIDATION. IT SHOULD BE NOTED THAT THE PACKAGED PRODUCT IS GAMMA IRRADIATED AT A RANGE OF 25KGY - 75 KGY. THIS PARTICULAR LOT (1122719) WAS IRRADIATED AT A DOSE OF 26.6 KGY - 37.99 KGY.

    Description of Event or Problem · 1

    THE PATIENT HAD A BIOPSY PROCEDURE PERFORMED WITH A PSS ARGENT 5.0MM BIOPSY PUNCH AND AN INFECTION AT THE SIGHT WAS CONFIRMED BY A POSITIVE CULTURE ON (B)(6) 2013. THE PATIENT WAS TREATED WITH ANTIBIOTICS SUCCESSFULLY WITH NO FURTHER TREATMENT NECESSARY OR NEEDED. THE PATIENT IS FINE.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention