BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8107754 · Received November 27, 2018

    Report

    Report Number
    2210968-2018-77357
    Event Type
    Injury
    Date Received
    November 27, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT 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? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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: TAIWANESE JOURNAL OF OBSTETRICS & GYNECOLOGY 56 (2017) 143-146; DOI: HTTP://DX.DOI.ORG/10.1016/J.TJOG.2016.05.014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "RADICAL TRACHELECTOMY FOR EARLY STAGE CERVICAL CANCER: A CASE SERIES AND LITERATURE REVIEW," AUTHORS: CHIN-JUI WU, WEN-CHUN CHANG, CHI-HAU CHEN, CHI-AN CHEN, SU-CHENG HUANG, BOR-CHING SHEU. CITATION: TAIWANESE JOURNAL OF OBSTETRICS & GYNECOLOGY 56 (2017) 143-146; DOI: HTTP://DX.DOI.ORG/10.1016/J.TJOG.2016.05.014. THE AIM OF THIS ARTICLE WAS TO COMPARE THE ONCOLOGIC AND PREGNANCY OUTCOMES OF RT IN THE PAST DECADE IN TAIWAN. BETWEEN 2002 AND 2015, 10 PATIENTS WITH EARLY STAGE CERVICAL CANCER UNDERWENT FERTILITY-PRESERVING RADICAL TRACHELECTOMY (RT). SEVEN PATIENTS UNDERWENT VAGINAL RT (VRT) AND 3 PATIENTS UNDERWENT ABDOMINAL RT (ART). IN VRT, THE LOWER UTERINE SEGMENT OF THE CERVIX WAS SUTURED WITH MERSILENE TAPE. IN ART, THE VAGINAL CUFF WAS SUTURED TO THE LOWER UTERINE SEGMENT WITH 1-0 COATED VICRYL SUTURES. CERCLAGE WAS PERFORMED VAGINALLY WITH THE USED OF MERSILENE TAPE. "A" (B)(6) AND (B)(6) FEMALE PATIENTS EXPERIENCED UNILATERAL HYDRONEPHROSIS (N=2) FOR WHICH ONE WAS TRANSIENT AND THE OTHER REQUIRED REGULAR URETER CATHETER REPLACEMENT. A (B)(6) FEMALE PATIENT DEVELOPED URINARY TRACT INFECTION (N=1) WHICH RESOLVED WITH ANTIBIOTIC TREATMENT. SHE ALSO DEVELOPED CERVICAL STENOSIS WHICH REQUIRED CERVICAL DILATATION TWICE. THE AUTHORS BELIEVED THAT LAPAROSCOPIC PELVIC LYMPHADENECTOMY AND VRT ARE SAFE AND FEASIBLE TREATMENT OPTIONS FOR PATIENTS WITH EARLY STAGE CERVICAL CANCER. THESE TREATMENT PROCEDURES ARE ASSOCIATED WITH SATISFACTORY ONCOLOGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948161 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE NEEDLE, CERCLAGE, GYNECOLOGICAL KDC ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention