BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERS TAPE WHT 30CMX5MM D/A CTX

    MDR report key: 8180339 · Received December 19, 2018

    Report

    Report Number
    2210968-2018-77899
    Event Type
    Injury
    Date Received
    December 19, 2018
    Report Date
    December 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    UDI-DI
    10705031049802
    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. 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 (MERSILENE TAPE) 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 (MERSILENE TAPE) USED IN THIS PROCEDURE? CITATION: J MATERN FETAL NEONATAL MED, 2016; 29(13): 2109¿2113; DOI: 10.3109/14767058.2015.1076786 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PHYSICAL EXAMINATION-INDICATED CERCLAGE IN SINGLETON AND TWIN PREGNANCIES: MATERNAL¿FETAL OUTCOMES" AUTHOR(S): ANDREA BERNABEU, MARIA GOYA, MIQUEL MARTRA, ANNA SUY, LAIA PRATCORONA, CARME MERCED, ELISA LLURBA, MANEL CASELLAS, ELENA CARRERAS, AND LUIS CABERO CITATION: J MATERN FETAL NEONATAL MED, 2016; 29(13): 2109¿2113; DOI: 10.3109/14767058.2015.1076786 THIS RETROSPECTIVE STUDY AIMED TO STUDY MATERNAL AND PERINATAL OUTCOMES AFTER PHYSICAL EXAMINATION-INDICATED CERCLAGE IN BOTH SINGLETON AND TWIN PREGNANCIES AND EVALUATE THE POSSIBLE RISK FACTORS ASSOCIATED. BETWEEN JAN2009 AND DEC2012, 60 FEMALE PATIENTS WITH SINGLETON (N=53) OR TWIN (N=3) PREGNANCIES DIAGNOSED WITH CERVICAL INCOMPETENCE AND IMMINENT RISK OF IMMATURE OR PRETERM BIRTH, UNDERWENT CERCLAGE. THE SHIRODKAR CERCLAGE TECHNIQUE WAS PERFORMED USING MERSILENE (ETHICON RS22, 5¿28 MM) UNDER SPINAL ANESTHESIA. OUTCOMES IN SINGLETON GROUP INCLUDED CHORIOAMNIONITIS (N=7), PREMATURE RUPTURE OF MEMBRANES (PROM) (N=16.7%) AND MISCARRIAGE AFTER CERCLAGE (N=4). OUTCOME IN TWIN PREGNANCY GROUP INCLUDED PROM (N=1). PHYSICAL EXAMINATION-INDICATED CERCLAGE FOR CERVICAL INCOMPETENCE IN WOMEN AT RISK FOR IMMATURE OR PRETERM BIRTH DEMONSTRATES GOOD PERINATAL PROGNOSIS WITHOUT INCREASING MATERNAL MORBIDITY IN EITHER SINGLETON OR TWIN PREGNANCIES. THE INCREASE IN GESTATION TIME IN OUR STUDY MAY ALSO HAVE BEEN DUE TO THE FACT THAT PATIENTS WITH SUBCLINICAL CHORIOAMNIONITIS WERE EXCLUDED BY DIAGNOSTIC AMNIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021302 MERS TAPE WHT 30CMX5MM D/A CTX CLASS I DEVICE - EXEMPT KDC ETHICON INC. 10705031049802

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention