BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTIMICROBIAL DRESSINGS (AMD )16-0044-0 4X4, ISLD DRESSING, STERILE 50/BX A50044

    MDR report key: 20409678 · Received October 8, 2024

    Report

    Report Number
    MW5160895
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 7, 2024
    Manufacturer
    UNK
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A REGISTERED NURSE (RN) CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE ADHESIVE ON 16-0044-0 ISLAND DRESSINGS. ALLERGY REPORTED IN EPS, VERY SENSITIVE SKIN. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295745 ANTIMICROBIAL DRESSINGS (AMD )16-0044-0 4X4, ISLD DRESSING, STERILE 50/BX A50044 DRESSING, WOUND, DRUG FRO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown