BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 8090651 · Received November 20, 2018

    Report

    Report Number
    2210968-2018-77253
    Event Type
    Injury
    Date Received
    November 20, 2018
    Report Date
    November 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    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. CITATION: J PAK MED ASSOC. 2012; 62 (6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "MORBIDITIES OF CERVICAL CERCLAGE: EXPERIENCE AT A TERTIARY REFERRAL CENTER." AUTHORS: SABA MUBASSHIR, SHAMA MUNIM, GHULAM ZAINAB. CITATION: J PAK MED ASSOC. 2012; 62 (6). THE OBJECTIVE OF THE STUDY WAS TO DETERMINE THE FREQUENCY OF OPERATIVE MORBIDITIES OF CERVICAL CERCLAGE. A TOTAL OF 70 WOMEN (AGE: 29.4 ± 5.2 YEARS) UNDERGOING CERVICAL CERCLAGE FROM APRIL 2007 TO DECEMBER 2009 AT THE AGA KHAN UNIVERSITY HOSPITAL SERVED AS THE STUDY SUBJECTS. THE SURGICAL TECHNIQUE USED WAS MCDONALD'S CERVICAL SUTURE USING MERSILENE TAPE (ETHICON) UNDER GENERAL ANESTHESIA. REPORTED COMPLICATIONS INCLUDED PREMATURE RUPTURE OF MEMBRANES (N-7) WHICH WERE MANAGED CONSERVATIVELY, FEVER (N-3) WHICH WAS MANAGED CONSERVATIVELY, PRE-TERM LABOR (N-14) WHICH WERE MANAGED CONSERVATIVELY BY GIVING PROGESTERONE SUPPOSITORIES BY VAGINAL/RECTAL ROUTE, AND VAGINAL BLEEDING (N-6) WHICH WERE MANAGED CONSERVATIVELY WITH BED REST AND VAGINAL PROGESTERONE 400 MG DAILY. THE RESULTS INDICATED THAT THE RISK OF MORBIDITIES LIKE RUPTURED MEMBRANES AND CHORIOAMNIONITIS REMAINED SMALL, BUT THE RISK OF PRE-TERM DELIVERY WAS HIGH. SAMPLE SIZE WAS A LIMITATION IN THE STUDY AND LARGER STUDY IS REQUIRED FOR SUBGROUP ANALYSIS AND FOR EXTERNAL VALIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932644 MERSILENE TAPE UNKNOWN PRODUCT INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention