BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPT MEDICAL ADHESIVE SPRAY

    MDR report key: 11612874 · Received April 5, 2021

    Report

    Report Number
    1480288-2021-00001
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    July 1, 2020
    Report Date
    April 5, 2021
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    KOX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER'S WEIGHT IS NOT KNOWN SO AN ESTIMATE WAS USED. A DHR REVIEW WAS PERFORMED ON THE PROVIDED LOT NUMBER. THE BATCH REVIEW RESULTS WERE ACCEPTABLE AND NO EVIDENCE OF ANY DEVIATIONS OR ABNORMALITIES WERE NOTED IN PRODUCTION. DESPITE REPEATED ATTEMPTS HOLLISTER HAS BEEN UNABLE TO REACH THE END USER FOR FURTHER INFORMATION. IT IS NOT KNOWN WHAT TYPE OF SKIN BREAKDOWN THE END USER EXPERIENCED OR HOW THE ADHESIVE SPRAY CAUSED OR CONTRIBUTED TO THIS REPORTED INJURY. A TREND ANALYSIS WAS CONDUCTED AND NO ADVERSE TRENDS WERE OBSERVED FOR THIS TYPE OF COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OSTOMATE STARTED TO EXPERIENCE SKIN BREAKDOWN IN (B)(6) 2020 WHILE USING HOLLISTER MEDICAL ADHESIVE SPRAY UNDER HER OSTOMY BARRIER. THE END USER STATED THAT THE SKIN BREAKDOWN WAS DUE TO THE MEDIAL ADHESIVE SPRAY. AS A RESULT OF THE BREAKDOWN, SHE REPORTED THAT SHE NEEDED TO HAVE SURGERY ON THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511618 ADAPT MEDICAL ADHESIVE SPRAY ADAPT MEDICAL ADHESIVE SPRAY KOX HOLLISTER INCORPORATED 9C188

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention