BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMIC GUT SURGICAL SUTURE, TREATED, ABSORBABLE

    MDR report key: 31373 · Received March 20, 1996

    Report

    Report Number
    MW4001110
    Event Type
    Malfunction
    Date Received
    March 20, 1996
    Report Date
    February 12, 1996
    Manufacturer
    LUKENS MEDICAL CORP.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LUKENS MED CORP. 500 LASER RD, RIO RANCHO, NM 87124. WHEN THE RETAINED PACKAGES WERE OPENED, THE SEALS ON BOTH THE PRIMARY AND SECONDARY PACKAGES WERE FOUND TO BE NORMAL AND ACCEPTABLE. THE SUTURE CARRIER AND SUTURE CONTAINED IN EACH OF THE PACKAGES WERE FOUND TO BE MOIST AND THE SUTURES WERE FOUND TO BE PLIABLE. 6.1 THE STERILITY STUDY RESULTS FOR BOTH THE WET AND DRY CONFIGURATIONS SHOWED ZERO POSITIVES AFTER 14 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMIC GUT SURGICAL SUTURE, TREATED, ABSORBABLE Implant SURGICAL SUTURE, SIZE 2-0 GAL LUKENS MEDICAL CORP. 0593/034

    Patients

    Seq Age Sex Outcome Treatment
    1 *