BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE

    MDR report key: 6705054 · Received July 12, 2017

    Report

    Report Number
    2210968-2017-32901
    Event Type
    Injury
    Date Received
    July 12, 2017
    Report Date
    December 13, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 07/11/2017. (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. REVIEWED FILE. ¿ WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? O IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. ¿ DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS / PDSII AND PDSII PLUS SUTURE, INVOLVED CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: SURGICAL SITE INFECTION. 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 DEVICES USED, PDSII AND PDSII PLUS SUTURE?

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT A LAPAROSCOPIC SURGERY FOR COLON CANCER ON UNKNOWN DATE AND THE SUTURE WAS USED FOR SURGICAL SITE OR DERMAL CLOSURE. THE PERITONEUM AND THE FASCIA WERE CLOSED TOGETHER AND KNOTTED SUTURE WAS PLACED. AFTER ABDOMINAL CLOSURE, THE SURGICAL SITE WAS COVERED WITH POLYURETHANE FILM DRESSING FOR 48 H AFTER SURGERY. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SURGICAL SITE INFECTION AND PUS FROM THE INFECTED SURGICAL SITES WAS CULTURED. CULTURES WERE POSITIVE FOR PATHOGENS AND THE CAUSATIVE ORGANISMS WERE BACTEROIDES SPECIES, ENTEROCOCCUS FAECALIS, PSEUDOMONAS AERUGINOSA, ESCHERICHIA COLI AND ENTEROBACTER CLOACAE. FOLLOW-UP COMPUTED TOMOGRAPHY OF THE CHEST AND ABDOMEN WAS PERFORMED EVERY SIX MONTHS AFTER THE PROCEDURE. THE SURGICAL SITE INFECTION WAS CONFIRMED, AND ADJUVANT CHEMOTHERAPY BEGAN WITHIN EIGHT WEEKS AFTER SURGERY. IT WAS POSSIBLE THAT THE PATIENT UNDERWENT FUNCTIONAL END-TO-END ANASTOMOSIS. DUE TO SSI, THE MEAN POSTOPERATIVE HOSPITAL STAY WAS EXTENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485833 PDS II POLYDIOXANONE SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R