BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7065317 · Received November 28, 2017

    Report

    Report Number
    2210968-2017-71469
    Event Type
    Injury
    Date Received
    November 28, 2017
    Report Date
    November 2, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 11/28/2017. (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON SUTURES CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? CITATION: EUR J CLIN MICROBIOL INFECT DIS 2015;34:2331-2338. DOI 10.1007/S10096-015-2485-8.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4) ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. NO DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT MONOCRYL PLUS AND/ OR MONOCRYL, VICRYL OR VICRYL PLUS SUTURES CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? NO IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿TRICLOSAN-COATED SUTURES AND STERNAL WOUND INFECTIONS: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL¿ THAT THE PURPOSE OF THIS PROSPECTIVE RANDOMIZED DOUBLE-BLIND SINGLE-CENTER STUDY WAS TO COMPARE THE RATE OF INFECTIONS IN STERNOTOMY WOUNDS CLOSED WITH TRICLOSAN-COATED OR CONVENTIONAL SUTURES. PATIENTS WERE RECRUITED BETWEEN MARCH 1, 2009 AND FEBRUARY 15, 2012. 357 PATIENTS WERE RANDOMIZED TO CLOSURE OF THE SURGICAL WOUNDS WITH EITHER TRICLOSAN-COATED SUTURES OR IDENTICAL SUTURES WITHOUT TRICLOSAN. WOUNDS OF PATIENTS IN THE NON-COATED GROUP (N=178; 28 WOMEN, 150 MEN; MEAN AGE 66.7+/-8.2; MEAN BMI 27.5+/-3.7 KG/M2) WERE CLOSED USING IDENTICAL SUTURES WITHOUT TRICLOSAN. STERNAL WOUND INFECTION OCCURRED IN 11.2% (N=20: DEEP INFECTION, N=4; SUPERFICIAL INFECTION, N=16) IN THE NON-TRICLOSAN GROUP. THERE WERE 17 POSITIVE CULTURES IN THE NON-COATED SUTURE GROUP. THE MOST COMMON PATHOGENS IN BOTH GROUPS WERE STAPHYLOCOCCUS AUREUS AND COAGULASE-NEGATIVE STAPHYLOCOCCI. ANTIBIOTIC-TREATED STERNAL WOUND INFECTION WAS 13.4% (N=24) FOR BOTH GROUPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844877 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention