BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 24404627 · Received February 20, 2026

    Report

    Report Number
    8043817-2026-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 20, 2026
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    UDI-DI
    00748426261611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS SUPPLIED BY MEDLINE/MICROTEK AS NON-STERILE FOR INCLUSION IN PROCEDURE KITS. STERILIZATION AND FINAL KIT ASSEMBLY ARE PERFORMED BY THE KIT PACKERS. SINCE DOWNSTREAM STERILIZATION AND KIT ASSEMBLY IS OUTSIDE THE MANUFACTURING SITE SCOPE FOR THIS COMPLAINT, THE INVESTIGATION FOCUSES ON THE REPORTED MATERIAL INTEGRITY ISSUE FOR THE PRODUCT AS SUPPLIED AND THE AVAILABLE PRODUCTION AND QUALITY RECORDS REVIEWED. ADDITIONAL REPORTED LOT NUMBERS ASSOCIATED WITH THIS COMPLAINT: D212351; 4073LRO000; 5084LRJ700.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL (16) PROBE COVERS WERE COMPROMISED INSIDE THE PACKAGING, WITH MATERIAL APPEARING DAMAGED AND ADHERED TO THE POUCH. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290327 MEDLINE-MICROTEK ROLLED PROBE COVER, 3.5 CM X 20 CM (1.4 IN X 8 IN) PUI MICROTEK MEDICAL LLC PC0907NS 4084LR1M00 00748426261611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown