BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPNG GZE 4X4IN CRTY 12 PLY PLN LF STRL

    MDR report key: 25240508 · Received May 20, 2026

    Report

    Report Number
    MW5188495
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 12, 2026
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE IDENTIFIED AN UNKNOWN SUBSTANCE WITHIN OUR GAUZE SPONGES PRIOR TO OUR PROCEDURE. WE HAVE SAVED THE CONTAINER AND PIECES OF GAUZE THAT CONTAINS THE SUBSTANCE. LET US KNOW WHO TO DROP THE ITEM OFF TOO FOR INVESTIGATION AND IF ANY FURTHER INFORMATION IS NEEDED. WE ATTEMPTED TO PLACE A PSR, BUT A USER ACCOUNT NEEDED TO BE MADE DUE TO NEW UPDATES TO THE SYSTEM. ONCE ACCOUNT IS APPROVED, A PSR WILL BE PLACED AND FORWARDED FOR DOCUMENTATION PURPOSES. LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. CARDINAL HEALTH MATERIAL NUMBER 6939G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214472 SPNG GZE 4X4IN CRTY 12 PLY PLN LF STRL FIBER, MEDICAL, ABSORBENT FRL CARDINAL HEALTH 6939G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown