BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON O-VICRYL/GU SUTURE

    MDR report key: 30575 · Received January 23, 1996

    Report

    Report Number
    30575
    Event Type
    Other
    Date Received
    January 23, 1996
    Date of Event
    October 30, 1995
    Report Date
    November 10, 1995
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR LAPAROSCOPIC CHOLECYSTECTOMY. WHILE CLOSING INCISION, NEEDLE BROKE APPROX IN HALF INTO SOFT TISSUE OF UPPER PORT SITE. UNABLE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON O-VICRYL/GU SUTURE ABSORBABLE SUTUREE GAM ETHICON, INC. J-376

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other