BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE

    MDR report key: 6708849 · Received July 12, 2017

    Report

    Report Number
    2210968-2017-32907
    Event Type
    Injury
    Date Received
    July 12, 2017
    Report Date
    December 13, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Removal / Correction Number
    NA
    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: 07/12/2017. (B)(4). IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ¿ WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? O IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. O DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS / SUTURES: MONOCRYL SUTURE, INVOLVED CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: INFECTION, ANTIBIOTICS, WOUND REVISION, HOSPITALIZATION , DEHISCENCE, SLOW ABSORPTION. O IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC SUTURE PRODUCT TYPE. ¿ PROVIDE PRODUCT CODES AND LOT NUMBERS. ¿ CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? O IF YES, PLEASE INCLUDE: DATE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ¿ ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR DEVICE USED? O MONOCRYL SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT ELECTIVE OR DAYTIME EMERGENCY PEDIATRIC/ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS POSSIBLE THAT THE PATIENT EXPERIENCED SUPERFICIAL OR DEEP SURGICAL SITE INFECTIONS WITHIN 30 DAYS AFTER SURGERY AND/OR WOUND DEHISCENCE, AND UNDERWENT A REVISION OF THE WOUND, SUTURE REMOVAL, FEWER VISITS TO THE PHYSICIAN OR READMISSION TO THE HOSPITAL, AND ANTIMICROBIAL COURSE TO TREAT SSI. IT WAS ALSO POSSIBLE THAT THE PATIENT EXPERIENCED SURGICAL SITE INFECTION MORE THAN 30 DAYS AFTER THE PROCEDURE, ON DAY 71 AFTER THORACOPLASTY; THE STERNAL PLATES WERE REMOVED DUE TO THE INFECTION. WOUND AND THE BLOOD BACTERIAL CULTURE WERE TAKEN AND POSSIBLY CONTAINED PSEUDOMONAS AERUGINOSA OR STAPHYLOCOCCUS AUREUS. IT WAS POSSIBLE THAT THE SUTURE WAS NOT ABSORBING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487129 MONOCRYL POLIGLECAPRONE 25 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R