BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISOPA SOLUTION

    MDR report key: 1041031 · Received May 9, 2008

    Report

    Report Number
    2084725-2008-00163
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    January 17, 2008
    Report Date
    April 15, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED, A CUSTOMER WITH A PT WHO HAD "SOME SORT" OF REACTION WHEN THEY UNDERWENT ECHOCARDIOGRAPHY. IT WAS REPORTED THAT SOME INSTRUMENTS USED IN ECHOCARDIOGRAPHY HAD NOT BEEN RINSED WELL AFTER DISINFECTED BY DISOPA. AT A LATER DATE, THE FACILITY REPORTED THAT THE PATIENT HAD A "CHEMICAL BURN" CONSISTING OF COLORING OF THE LIPS, TONGUE, AND PHARYNX, AS WELL AS WHEEZING, DIFFICULTY BREATHING, AND DYSPHAGIA. THE CUSTOMER REPORTED THAT THE DISCOLORATION WAS NOTED ABOUT EIGHT HOURS AFTER THE PROCEDURE BEGAN. THE CUSTOMER DID NOT PROVIDE TREATMENT INFORMATION FOR THE PATIENT. IT WAS REPORTED THAT THE CUSTOMER SOAKED THE TEE PROBE IN DISOPA FOR ONE WEEK AND THEN RINSED FOR FIVE MINUTES. RINSING PROCEDURE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION DISINFECTANT LRJ JOHNSON & JOHNSON 17800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK