BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC MONOSOF 10/0

    MDR report key: 84043 · Received April 14, 1997

    Report

    Report Number
    1219930-1997-00834
    Event Type
    Malfunction
    Date Received
    April 14, 1997
    Report Date
    March 20, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    1/13/1998-SUPPLEMENTAL REPORT #1 SENT TO FDA.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC MONOSOF 10/0 Implant MONOFILAMENT NYLON SUTURE GAR UNITED STATES SURGICAL CORP. NA A6J401W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN