BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC SURGIPRO 3/0

    MDR report key: 76766 · Received March 11, 1997

    Report

    Report Number
    1219161-1997-00262
    Event Type
    Malfunction
    Date Received
    March 11, 1997
    Report Date
    February 13, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CO COULD NOT CONFIRM THE REPORTED CONDITION AS THE STRAND OF SUTURE RETURNED WAS NOT BROKEN. HOWEVER, THE NEEDLE PERMATURELY DETACHED.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE. THE HOSP REPORTED THAT NO PT INJURY HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC SURGIPRO 3/0 Implant POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN