BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL OB PACK

    MDR report key: 801383 · Received December 2, 2004

    Report

    Report Number
    9611594-2004-00050
    Event Type
    Malfunction
    Date Received
    December 2, 2004
    Date of Event
    November 8, 2004
    Report Date
    December 2, 2004
    Manufacturer
    AVENT SA DE DE C.V.
    Product Code
    HFW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UMBILICAL CORD CLAMP IS ONE COMPONENT OF KIMBERLY-CLARK'S SURGICAL OB PACK. THE CORD CLAMP IS CONTRACT MANUFACTURED FOR KIMBERLY-CLARK CORP. AN UNUSED CORD CLAMP (NEW) IS REPORTEDLY BEING RETURNED TO KIMBERLY-CLARK (AVENT SA DE CV), BY THE HOSP, FOR EVAL.

    Description of Event or Problem · 1

    A HOSP REPORTED THAT A NEWBORN INFANT "LOST A LARGE AMOUNT OF BLOOD" WHEN THE UMBILICAL CORD CLAMP, THAT WAS APPLIED, DID NOT CLOSE PROPERLY. NO PT INJURY OR MEDICAL INTERVENTION WERE REPORTED. KIMBERLY-CLARK CORP. HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS BUT IS RELAYING INFO REC'D FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL OB PACK UMBILICAL CORD CLAMP HFW AVENT SA DE DE C.V. NA AA425901B

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention