BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED GAUZE SPONGE,STERILE 2'S,2X2X4 PLY, NON-WOVEN

    MDR report key: 21143364 · Received January 10, 2025

    Report

    Report Number
    MW5164600
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 8, 2025
    Manufacturer
    AMD- RITMED/AMD MEDICOM INC.
    Product Code
    NAB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT SHE'S HAVING AN ALLERGIC REACTION / RASH TO THE GAUZE SPONGE. 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
    2212053 AMD-RITMED GAUZE SPONGE,STERILE 2'S,2X2X4 PLY, NON-WOVEN GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE NAB AMD- RITMED/AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown