BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 24848271 · Received April 11, 2026

    Report

    Report Number
    8043817-2026-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 10, 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

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE MATERIAL WAS DAMAGED LIKE IT HAD DISINTEGRATED AND STUCK TO THE POUCH. THE PRODUCT INVOLVED WAS (B)(4), 1 CS (B)(4) UNITS) WERE REPORTED AFFECTED. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913168 MEDLINE-MICROTEK ROLLED PROBE COVER, 3.5 CM X 20 CM (1.4 IN X 8 IN) PUI MICROTEK MEDICAL LLC PC0907NS 5084LRJ700 00748426261611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown