BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERS MESH

    MDR report key: 7824450 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75496
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Report Date
    August 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THE EXPIRATION DATE ON THE INDIVIDUAL PACKS OF THE MESH IN THE BOX? NO. CAN YOU PROVIDE PICTURES? ATTACHED. SALES REP. REPORTED THAT THE DEVICES WERE DISCARDED, NO PRODUCT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    PC-(B)(4). IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2018-75496 IS NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR AN UNKNOWN HERNIA REPAIR IN 2018, THERE WAS NO EXPIRATION DATE LISTED ON THE MESH BOX OR INDIVIDUAL POUCH. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662712 MERS MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. JKP762

    Patients

    Seq Age Sex Outcome Treatment
    1