BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11715622 · Received April 23, 2021

    Report

    Report Number
    11715622
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 14, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OHG
    UDI-DI
    10884389542040
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    HEALTH CARE PROVIDER REPORTED HEMOSTAT DID NOT CLAMP CORRECTLY. THERE WAS A GAP IN THE INSTRUMENT.

    Description of Event or Problem · 1

    HEALTH CARE PROVIDER REPORTED THAT THE HEMOSTATIC FORCEPS DID NOT CLAMP CORRECTLY AS THERE WAS A GAP IN THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616239 MEDLINE INDUSTRIES, INC. CIRCUMCISION TRAY OHG MEDLINE INDUSTRIES, INC. DYNDF1072A 10884389542040

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA