BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXON* 1 GRN 150CM LP KV37X12

    MDR report key: 4111159 · Received September 23, 2014

    Report

    Report Number
    1219930-2014-00849
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    PMA / PMN Number
    K990951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTROINTESTINAL. ACCORDING TO THE REPORTER: LAPAROTOMY WOUND WITH SMALL INTESTINE RESECTION. AFTER USAGE OF MAXON GMM873L FOR CLOSING ABDOMINAL WALL, SUTURED FASCIA OPENED UP. THE SUTURE MATERIAL DID NOT GROW IN AND WAS RIPPED OUT. THERE WAS A SECOND SURGERY REQUIRED TO CLOSE THE BUSTED SUTURE: LAPAROTOMY WOUND WAS COMPLEATLY UNDERMINED AT TOTAL LENGTH, THE WOUND GROUND WAS PARTIALLY NECROTIC. WITH FIBRIN COVERED FASCIA AT BARE EXPOSED MAXON LOOP. AT INITIAL SURGERY: NO EXTENSION OF INCISION OR SURGERY TIME, NO BLOOD LOSS, NO TISSUE DAMAGE, NO CHANGE OF PROCEDURE, NO PART FELL INTO CAVITY, NO REINFORCEMENT MATERIAL USED. PATIENT FEMALE, (B)(6) YEARS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL. WHAT IS THE DATE OF THE ORIGINAL SURGERY AND WHAT IS THE DATE OF THE REOPERATION? ORIGINAL SURGERY: (B)(6) 2014" REOPERATION (B)(6) 2014. WHAT WAS THE PATIENT'S ORIGINAL DIAGNOSIS? WILL BE CHECKED WITH CLINIC. WHAT WERE THE FINDINGS AT THE TIME OF THE REOPERATION? LAPAROTOMY WOUND WAS COMPLETELY UNDERMINED AT TOTAL LENGTH , THE WOUND GROUND WAS PARTIALLY NECROTIC. WITH FIBRIN COVERED FASCIA AT BARE EXPOSED MAXON LOOP. WHAT IS MEANT BY THE SUTURE WAS RIPPED? SUTURE WAS OPEN SINCE WOUND WAS UNDERMINED AT PARTIAL NECROTIC. DID THE PATIENT HAVE RADIATION OR CHEMOTHERAPY PRIOR TO THE SURGERY? WILL BE CHECKED WITH CLINIC. WHAT WAS THE PATIENT'S PREOPERATIVE MEDICAL HISTORY? DID THAT PATIENT HAVE ANY OF THE FOLLOWING: DIABETES, OBESITY, HYPERTENSION, CORONARY ARTERY DISEASE, PERIPHERAL VASCULAR DISEASE, LIVER DISEASE, KIDNEY DISEASE, AUTOIMMUNE DISORDERS, COPD/ASTHMA/EMPHYSEMA, STEROID USE? THE LOT NUMBERS FOR US201408-2037, US201408-2042, US201408-2044, AND US201408-2049 ARE ALL THE SAME. CAN YOU CONFIRM THIS? ADDITIONALLY, WERE ALL SUTURES FROM THE SAME BOX? CANNOT BE CONFIRMED ONLY ASSUMED. MATERIAL FROM SITUS WILL BE SEND IN ONLY FOR US201408-2037. I NOTICED UNDER NOTES THAT ALL FOUR FTR'S WERE THE SAME PROBLEM WITH THE SAME CLIENT. CAN YOU CONFIRM THAT THESE WERE FOUR SEPARATE PATIENTS/SURGERIES? YES ALL SEPARATE PATIENTS/SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592158 MAXON* 1 GRN 150CM LP KV37X12 MAXON GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON GMM873L B3K1816X

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other