BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE

    MDR report key: 4093861 · Received September 16, 2014

    Report

    Report Number
    2210968-2014-12954
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL CERCLAGE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A LOCAL ALLERGIC REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571144 MERSILENE POLYESTER FIBER SUTURE SUTURE, NONABSORBABLE GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention