BEUDAMED
    FDA Adverse Event Other Summary report: N

    4X4, ISLAND DRESSING, STERILE

    MDR report key: 20211665 · Received September 12, 2024

    Report

    Report Number
    MW5159557
    Event Type
    Other
    Date Received
    September 12, 2024
    Report Date
    September 9, 2024
    Manufacturer
    UNK
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO (B)(6) MEDICAL CARE THAT THESE DRESSING ARE TEARING THE SKIN WHEN WE USE TO REMOVE THEM FROM CVC SITE. 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
    1112382 4X4, ISLAND DRESSING, STERILE DRESSING, WOUND, DRUG FRO UNK A50044 9611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown