BEUDAMED
    FDA Adverse Event Other Summary report: N

    1059020-2013-00008

    MDR report key: 3110512 · Received May 13, 2013

    Report

    Report Number
    1059020-2013-00008
    Event Type
    Other
    Date Received
    May 13, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 15, 2013
    PMA / PMN Number
    K921822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (1231320) WAS IRRADIATED AT A DOSE OF 25.2 KGY - 33.9 KGY.

    Description of Event or Problem · 1

    PATIENT REPORTED REDNESS, SWELLING AND TENDERNESS ON UPPER RIGHT ARM. PATIENT WAS SEEN BY (B)(6) AND TREATED WITH ANTIBIOTICS. NO FURTHER CONTACT WITH PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention