BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERALDECIDE

    MDR report key: 2973726 · Received July 20, 2007

    Report

    Report Number
    1221361-2007-00001
    Event Type
    Injury
    Date Received
    July 20, 2007
    Date of Event
    June 20, 2005
    Report Date
    July 10, 2007
    Manufacturer
    ALDEN MEDICAL LLC
    Product Code
    MED
    PMA / PMN Number
    K962959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING DIALYSIS TREATMENT ON (B)(6) 2005. DURING TREATMENT, PT REPORTED SHARP STINGING SENSATION. A REVIEW BY INSTITUTION PERSONNEL REVEALED AN IMPROPER EQUIPMENT SET UP, WHICH MAY HAVE RESULTED IN A SMALL AMOUNT OF DISINFECTANT ENTERING THE SALINE LINE AND INFUSING INTO THE PT DURING DIALYSIS. THIS EVENT WAS NOT REPORTED TO MANUFACTURER BY THE INSTITUTION. THIS EVENT WAS REPORTED TO THE MANUFACTURER BY A FAMILY MEMBER OF THE PT IN (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERALDECIDE PERACETIC ACID DISINFECTANT MED ALDEN MEDICAL LLC NA 1507127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization