BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM KELLY CLAMP OR KELLY FORCEPS

    MDR report key: 13043058 · Received December 17, 2021

    Report

    Report Number
    MW5106149
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    October 7, 2021
    Report Date
    December 15, 2021
    Manufacturer
    SPECTRUM SURGICAL SUPPLIES
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT DELIVERED VIA C/S. CORD CLAMPED WITH KELLY AND CUT. INFANT HANDED OFF TO OB RN. WHEN OB RN SET INFANT IN WARMER, NOTED BLOOD ON BLANKET. WAS FOUND THAT KELLY CLAMP HAD COME UNCLAMPED. RN QUICKLY CLAMPED THE KELLY TO STOP BLEEDING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932551 SPECTRUM KELLY CLAMP OR KELLY FORCEPS FORCEPS, GENERAL & PLASTIC SURGERY GEN SPECTRUM SURGICAL SUPPLIES

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female