BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING, STERILE 50/BX A50044

    MDR report key: 21827691 · Received April 11, 2025

    Report

    Report Number
    MW5168908
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 9, 2025
    Manufacturer
    AMD-RITMED, 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) PATIENT CONTACTED (B)(6) TO REPORT THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE ISLAND DRESSINGS. HE FIRST STARTED USING THEM TWO WEEKS AGO. THE SKIN AROUND HIS CATHETER WAS RED, BUMPY AND ITCHY. THEY WENT TO SEE A DERMATOLOGIST AND HE SUGGESTED THEY STOP USING THE ISLAND DRESSINGS. ONCE THEY STOPPED USING THEM HIS SKIN IMPROVED. THE PATIENT HAS ONLY RECEIVED ISLAND DRESSINGS FROM THE FIRST DELIVERY, ORDER (B)(4). NO PICKUP IS NEEDED, THE PATIENT INVOLVEMENT IS UNKNOWN HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED. 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
    1006981 AMD-RITMED 4X4, ISLAND DRESSING, STERILE 50/BX A50044 DRESSING, WOUND, DRUG FRO AMD-RITMED, INC. 12870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown