BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHRONIC CATGUT SUTURES

    MDR report key: 84722 · Received April 18, 1997

    Report

    Report Number
    9681850-1997-00006
    Event Type
    Injury
    Date Received
    April 18, 1997
    Report Date
    March 21, 1997
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY REVIEWS WERE UNREMARKABLE. RETAINED SAMPLES WERE EVALUATED FOR KNOT-PULL STRENGTH AND IN VIVO USE. PULL STRENGTH RESULTS WERE WITHIN USP SPECIFICATIONS FOR ALL LOTS. IN VIVO TESTING WERE SATISFACTORY. A SEARCH OF RECORDS FOUND NO OTHER COMPLAINTS AGAINST THESE THREE LOTS. NO REASON OR CAUSE COULD BE FOUND FOR THE REPORTED PROBLEM. CO BELIEVES THESE SUTURES SHOULD HAVE PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, DEVICE EASILY CUT, FRAYING AND LEADS TO REACTION ENDING TO DEHISCENCE OF THE WOUND AT THE SITE OF THE SUTURE TILL THE SUTURE MATERIAL CAME OUT OF THE WOUND. NO SIGNS OF INFECTION, CLEAR SERUM, NO PAIN, NO EDEMA AND NO REDNESS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHRONIC CATGUT SUTURES Implant SURGICAL SUTURE GAL DAVIS & GECK, INC. NA 263209, 112278, 327633

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other