BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4

    MDR report key: 21143306 · Received January 10, 2025

    Report

    Report Number
    MW5164599
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    November 14, 2024
    Report Date
    January 8, 2025
    Manufacturer
    AMD- RITMED/AMD MEDICOM, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PRODUCT LISTED IN THIS COMPLAINT IS A DISTRIBUTED PRODUCT. A LETTER HAS BEEN SENT TO BOTH THE CUSTOMER AND THE MANUFACTURER REGARDING THIS ISSUE. THE MANUFACTURER WILL FOLLOW UP WITH THE CUSTOMER FOR FURTHER INVESTIGATION. 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
    2212052 AMD-RITMED 4X4 DRESSING, WOUND, OCCLUSIVE NAD AMD- RITMED/AMD MEDICOM, INC. 10941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown