BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAIN SPONGE, STERILE

    MDR report key: 22944042 · Received September 2, 2025

    Report

    Report Number
    MW5175528
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 18, 2025
    Report Date
    August 27, 2025
    Manufacturer
    AMD-RITMED, INC./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 STATING THAT DRAIN SPONGE, STERILE 2'S,2X2X6PLY-NONWV HE IS ALLERGIC TO THE TAPE. 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
    1335551 DRAIN SPONGE, STERILE GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE NAB AMD-RITMED, INC./AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown