BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4, ISLAND DRESSING, STERILE 50/BX

    MDR report key: 22169878 · Received June 9, 2025

    Report

    Report Number
    MW5171199
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    April 29, 2025
    Manufacturer
    AMD-RITMED/ AMD MEDICOM INC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT A COMPLAINT REGARDING THE 4"X4"ISLAND DRESSING, STERILE 50/BX. THE PATIENT REPORTED HAS ITCHING AND A RASH WHEN USING THE 4X4 ISLAND DRESSING. THERE WAS PATIENT INVOLVEMENT, PATIENT REACTION (ITCHING AND RASH), NO MEDICAL INTERVENTION 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
    90084 4X4, ISLAND DRESSING, STERILE 50/BX DRESSING, WOUND, DRUG FRO AMD-RITMED/ AMD MEDICOM INC A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown