BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING

    MDR report key: 20811498 · Received November 27, 2024

    Report

    Report Number
    MW5162984
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 26, 2014
    Manufacturer
    AMD- RITMED/AMD MEDICOM, INC,
    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

    A PERITONEAL DIALYSIS (PD) REGISTERED NURSE CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE PATIENT HAS CONTACT DERMATITIS FROM THE 4X4, ISLAND DRESSING, STERILE 50/BX A50044 THAT IS MANUFACTURED BY (B)(4). THE NURSE DOES NOT HAVE THE LOT OR EXPIRATION DATE OF THE PRODUCT. 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
    304593 AMD-RITMED 4X4, ISLAND DRESSING DRESSING, WOUND, DRUG FRO AMD- RITMED/AMD MEDICOM, INC,

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown