BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 20657568 · Received November 11, 2024

    Report

    Report Number
    2210968-2024-11827
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    January 13, 2022
    Report Date
    November 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ULTRASOUND OBSTET GYNECOL 2022; 59: 169¿176. HTTPS://DOI.ORG/10.1002/UOG.23708.

    Description of Event or Problem · 0

    TITLE: INTERVENTIONS TO PREVENT PRETERM DELIVERY IN WOMEN WITH SHORT CERVIX BEFORE FETOSCOPIC LASER SURGERY FOR TWIN¿TWIN TRANSFUSION SYNDROME. THE OBJECTIVE OF THIS STUDY WAS TO COMPARE SECONDARY METHODS FOR THE PREVENTION OF PRETERM BIRTH IN TWIN PREGNANCIES WITH TTTS UNDERGOING FETOSCOPIC LASER PHOTOCOAGULATION (FLP), IN THE SETTING OF A SHORT CERVIX AT THE TIME OF FLP, IN FIVE NORTH AMERICAN FETAL TREATMENT NETWORK (NAFTNET) CENTERS. THIS WAS A SECONDARY ANALYSIS OF DATA COLLECTED PROSPECTIVELY FROM PREGNANCIES WITH TTTS UNDERGOING FLP THAT HAD A COMORBID SHORT CERVIX, BETWEEN JANUARY 2013 AND MARCH 2020. A TOTAL OF 255 WOMEN WITH A SHORT CERVIX UNDERGOING FLP FOR TTTS MET THE INCLUSION CRITERIA. CERVICAL CERCLAGE WAS PERFORMED USING A MODIFIED MCDONALD TECHNIQUE18, EITHER BEFORE OR AFTER FLP, USING EITHER MERSILENE TAPE (ETHICON INC., SOMERVILLE, NJ, USA), #5 TICRON (COVIDIAN, NORTH HAVEN, CT, USA) OR 0-PROLENE (ETHICON INC.). THE REPORTED COMPLICATIONS INCLUDED PRETERM PREMATURE RUPTURE OF MEMBRANES (N=?). IN CONCLUSION, A LARGE PROPORTION OF PREGNANCIES WITH TTTS AND A SHORT MATERNAL CERVIX UNDERGOING FLP WERE MANAGED EXPECTANTLY FOR A SHORT CERVIX, ESTABLISHING A HIGH (62%) RISK OF DELIVERY BEFORE 32 WEEKS IN THIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975210 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other