BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXON 4-0 18" CLEAR PRE-302

    MDR report key: 227370 · Received June 9, 1999

    Report

    Report Number
    9681850-1999-00005
    Event Type
    Malfunction
    Date Received
    June 9, 1999
    Report Date
    May 12, 1999
    Manufacturer
    THE KENDALL CO (UK) LTD.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXON 4-0 18" CLEAR PRE-302 Implant MONOFILAMENT SYNTHETIC SUTURE GAN THE KENDALL CO (UK) LTD. NA 651678

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN