BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7694707 · Received July 17, 2018

    Report

    Report Number
    2210968-2018-74441
    Event Type
    Injury
    Date Received
    July 17, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: BIOMEDICAL RESEARCH. 2017; 28 (15): 6611 6614. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPARISON OF EFFICACY BETWEEN BLIND AND DIRECT VISION FLAP TRIMMING FOR THE TREATMENT OF AXILLARY OSMIDROSIS" AUTHOR: GUO LIU, LIPING ZHOU, WENHAO ZHANG CITATION: BIOMEDICAL RESEARCH. 2017; 28 (15): 6611 6614. THE OBJECTIVES OF THE STUDY WAS TO INVESTIGATE THE CLINICAL EFFECT OF FLAP TRIMMING OPERATION UNDER DIRECT VISION AND BLINDNESS IN THE TREATMENT OF AXILLARY OSMIDROSIS. A TOTAL OF 100 PATIENTS (58 MALE AND 42 FEMALE PATIENTS; AGE RANGE: 14 TO 46 YEARS OLD) WITH BILATERAL OSMIDROSIS AXILLAE OUTPATIENTS WHO CAME TO OUR HOSPITAL DURING SEP 2012 TO DEC 2015 WERE SELECTED IN THIS STUDY. OF WHICH, 50 PATIENTS RECEIVED FLAP TRIMMING OPERATION UNDER DIRECT VISION WHILE THE OTHER 50 PATIENTS RECEIVED FLAP TRIMMING OPERATION UNDER BLINDNESS. DURING THE FLAP TRIMMING OPERATION UNDER DIRECT VISION PROCEDURE, LACUNAE WERE CHECKED TO MAKE SURE THAT THERE WAS NO ACTIVE BLEEDING. INCISIONS INCLUDING A SMALL AMOUNT OF BASE TISSUES WERE SUTURED USING MERSILK 5-0 AT A SMALL INTERVAL. IN THE SURGERY AREA EDGE, 3 GROUPS OF BALING LINES WERE SUTURED USING MERSILK 3-0. DRESSINGS WERE PACKED AND PRESSURED. SELF-ADHESIVE BANDAGE WHICH WAS BANDAGED AND PRESSURED APPROPRIATELY WAS USED OUTSIDE THE DRESSING. IN THE FLAP TRIMMING OPERATION UNDER DIRECT VISION PROCEDURE, REPORTED COMPLICATION INCLUDED DELAYED WOUND HEALING (N-3) AND BILATERAL BLEEDING (N-4). IT WAS CONCLUDED THAT FLAP TRIMMING METHOD WAS WIDELY ADOPTED FOR TREATMENT OF AXILLARY OSMIDROSIS. BOTH TECHNIQUES ARE EFFECTIVE AND PHYSICIANS CAN CHOOSE ANY OPERATION ACCORDING TO THE EXPERIENCE AND THE PATIENT¿S SPECIFIC SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538216 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention