BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 SURGILENE

    MDR report key: 27453 · Received October 25, 1995

    Report

    Report Number
    MW1007432
    Event Type
    Injury
    Date Received
    October 25, 1995
    Date of Event
    September 25, 1995
    Report Date
    October 2, 1995
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN THE MEDWATCH FORM SUBMITTED TO THE FDA BY THE SURGEON, THE LOT NUMBER WAS NOT INDICATED. DURING FOLLOW-UP CONTACT WITH THE SURGEON, HE NOTED THAT THE LOT NUMBER HAD NOT BEEN RECORDED DURING SURGERY AND IT WAS NO LONGER POSSIBLE FOR THE OPERATING ROOM STAFF TO DETERMINE THE NUMBER. HOWEVER, BASED ON A SEARCH THROUGH SALES RECORDS, CO WAS ABLE TO IDENTIFY TWO LOT NUMBERS POSSIBLY ASSOCIATED WITH THE REPORTED EVENT. THE LOT NUMBERS ARE 930302 AND 936520. INFO OBTAINED FROM SURGEON CONFIRMED THAT A MALE PT SUSTAINED A GUNSHOT WOUND AND BLUNT TRAUMA TO ABDOMEN. THE OPERATIVE PROCEDURE WAS AN EMERGENCY EXPLORATORY LAPAROTOMY, TOGETHER WITH REPAIR OF A DIAPHRAGMATIC INJURY, RESECTION OF INJURED COLON WITH REANASTOMOSIS, & DRAINAGE OF A PANCREATIC INJURY. APPROX. 10 DAYS POST-OPERATIVELY, PT EVISCERATED, WHICH NECESSITATED REOPERATION. ON RE-EXPLORATION, SUTURES WERE NOTED TO BE BROKEN. PT HAD A DIFFICULT POST-OPERATIVE COURSE. RETENTION SUTURE SAMPLES WERE OBTAINED FOR EACH OF ABOVE TWO LOTS. SUTURES WERE THEN TESTED FOR KNOT-PULL TENSILE STRENGTH PER U.S.P.23. RESULTS INDICATED THAT KNOT-PULL TENSILE STRENGTH VALUES OF TWO LOTS WERE SATISFACTORY. ALL VALUES EXCEEDED THE U.S.P. SPECIFICATION. NO ADD'L INFO WAS OFFERED BY ATTENDING SURGEON DURING FOLLOW-UP TELEPHONE CONTACT. A REVIEW OF QUALITY CONTROL RECORDS WAS PERFORMED. RESULTS INDICATED THE KNOT-PULL TENSILE STRENGTH VALUES OF ABOVE TWO LOTS MET U.S.P. SPECIFICATION WHEN TESTED PRIOR TO LOT RELEASE. IN ADDITION, THERE HAD BEEN NO OTHER COMPLAINT REPORTS CONCERNING EITHER OF TWO LOTS SINCE THEIR RELEASE. CO HAS FOUND NO EVIDENCE INDICATING THAT REPORTED EVENT WAS ATTRIBUTABLE TO DEVICE. ANALYSIS OF REPORTED EVENTS AND SALES DATA FOR 1994 AND 1995 DEMONSTRATES A FREQUENCY OF OCCURRENCE OF 0.0004% AND 0.0002%, RESPECTIVELY. THEREFORE, THERE IS NO INCREASING TREND IN FREQUENCY OF OCCURRENCE. IN ADDITION, NO SIGNIFICANT CHANGE IN SEVERITY PATTERN WAS NOTED. BASED ON FAILURE ANALYSIS AND LABORATORY EVALUATION RESULTS, CO HAS FOUND NO EVIDENCE INDICATING THAT REPORTED EVENT WAS ATTRIBUTABLE TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 SURGILENE Implant SURGICAL SUTURE GAW DAVIS & GECK, INC. T-20, 48MM

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization