BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8056237 · Received November 9, 2018

    Report

    Report Number
    2210968-2018-77078
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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: JOURNAL DE GYNECOLOGIE OBSTETRIQUE ET BIOLOGIE DE LA REPRODUCTION. 2017; 46: 53-59. DOI: HTTP://DX.DOI.ORG/10.1016/J.JGYN.2016.09.006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "EFFECTIVENESS OF ELECTIVE CERVICAL CERCLAGE ACCORDING TO OBSTETRIC HISTORY," AUTHORS: D. KORB, P. MARZOUK, J. DEU, J.-F. OURY, O. SIBONY. CITATION: JOURNAL DE GYNECOLOGIE OBSTETRIQUE ET BIOLOGIE DE LA REPRODUCTION. 2017; 46: 53-59. DOI: HTTP://DX.DOI.ORG/10.1016/J.JGYN.2016.09.006. THE OBJECTIVES OF THE STUDY WAS TO ASSESS THE EFFECTIVENESS OF ELECTIVE HISTORY-INDICATED CERVICAL CERCLAGE ACCORDING TO OBSTETRICAL HISTORY. THE AUTHORS ANALYZED PREGNANCY OUTCOME OF A RETROSPECTIVE COHORT OF 205 WOMEN (AGE RANGE: 21 TO 46 YEARS OLD; BMI: 15 TO 55) WHO HAVE HAD HISTORY-INDICATED MCDONALD¿S CERCLAGE. PRINCIPAL OUTCOME WAS GESTATIONAL AGE (GA) AT DELIVERY. CERVICAL CERCLAGE WAS PERFORMED USING MCDONALD¿S TECHNIQUE, WITH ONE STITCH OF MERSILENE 5 MM TAPE (ETHICON), PLACED IN A PURSE-STRING FASHION. IT WAS INSERTED AS A PROPHYLACTIC MEASURE IN ASYMPTOMATIC WOMEN, USUALLY AT 12¿14 WEEKS¿ GESTATION, FOLLOWING ASSESSMENT OF VIABILITY BY ULTRASOUND GUIDANCE AND CHROMOSOMAL RISK. REPORTED POST-OPERATIVE COMPLICATIONS INCLUDED CHORIOAMNIONITIS (N-10), UTERINE CONTRACTIONS (N-43), AND PRE-TERM DELIVERY (N-65). ELECTIVE CERCLAGE APPEARS TO BE A SIMPLE AND EFFECTIVE TECHNIQUE WHEN ITS INDICATION IS BASED ON A SUGGESTIVE HISTORY OF CERVICAL INSUFFICIENCY. ITS EFFECTIVENESS EVIDENCE IS EVEN MORE RELIABLE BY A STANDARDIZED REALIZATION. ELECTIVE CERVICAL CERCLAGE SHOULD BE RECOMMENDED TO WOMEN WITH ONE OR TWO PRIOR PTB OR STL OR WITH A SUGGESTIVE CERVICAL INSUFFICIENCY HISTORY OR WITH A PRIOR SUCCESSFUL CERCLAGE. BY CONTRAST, AN ALTERNATIVE TO CERVICAL CERCLAGE COULD BE OFFERED TO WOMEN WITH A HISTORY OF THREE AND MORE PRIOR PT OR STL OR CERCLAGE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895509 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention