BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7679022 · Received July 11, 2018

    Report

    Report Number
    2210968-2018-74263
    Event Type
    Injury
    Date Received
    July 11, 2018
    Report Date
    June 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: INDIAN J SURG (DECEMBER 2015) 77 (SUPPL 3): S1148¿S1153; DOI 10.1007/S12262-015-1224-9. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2018-74263 IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: RESPONSE RECEIVED FROM AUTHOR: I DO NOT BELIEVE THE SUTURE WAS DIRECTLY OR INDIRECTLY RESPONSIBLE. WE USED THE SAME SUTURE IN BOTH STUDY AND CONTROL GROUPS. ALSO USED THE SAME TECHNIQUE. I HAVE IN NO WAY IMPLICATED ANY COMPLICATION ON A SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL AUTHOR: "TITLE: FAST-TRACKING COLOSTOMY CLOSURES". AUTHOR(S): ADITYA J. NANAVATI & SUBRAMANIAM PRABHAKAR. CITATION: INDIAN J SURG (DECEMBER 2015) 77 (SUPPL 3): S1148¿S1153; DOI 10.1007/S12262-015-1224-9. THIS RETROSPECTIVE STUDY AIMED TO ANALYSE PERIOPERATIVE PERIOD AND RECOVERY IN COLOSTOMY CLOSURES TO CONFIRM THAT FAST-TRACK SURGERY PRINCIPLES IMPROVED OUTCOMES. DURING THE 4-YEAR PERIOD FROM MAY 2009 TO APR 2013, 50 PATIENTS UNDERWENT COLOSTOMY CLOSURE AND WERE ALLOCATED INTO FAST-TRACK ARM (N=26; N=14 MALE AND N=12 FEMALE; MEAN AGE SD OF 32.46±11.19 YEARS) AND CONVENTIONAL CARE ARM (N=24; N=15 MALE AND N=9 FEMALE; MEAN AGE SD OF 34.46±15.5 YEARS). THE DOUBLE LAYER HAND-SEWN ANASTOMOSIS WAS ACHIEVED USING 3-0 MERSILK SUTURES IN ALL CASES. POSTOPERATIVELY IN FAST-TRACK GROUP COMPLICATIONS INCLUDED POST-OPERATIVE ILEUS DUE TO ANASTOMOTIC LEAKAGE (N=1), WOUND INFECTION (N=1) FOR WHICH PATIENT WAS RE-ADMITTED AND WOUND DEHISCENCE (N=1). IN CONVENTIONAL GROUP, COMPLICATION INCLUDED WOUND INFECTION (N=2) FOR WHICH ONE PATIENT REQUIRED RE-ADMISSION DUE TO SEVERE WOUND INFECTION. IT CAN BE SAFELY CONCLUDED THAT SURGERIES LIKE COLOSTOMY CLOSURES MAY BE PERFORMED UNDER THE UMBRELLA OF A FAST-TRACK SURGERY PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521119 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention