BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 4915564 · Received July 15, 2015

    Report

    Report Number
    2210968-2015-08483
    Event Type
    Injury
    Date Received
    July 15, 2015
    Report Date
    June 24, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 07/15/2015 (B)(4). CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND SUTURE WAS USED TO CLOSE THE CHEST OF THE PATIENT. THE SURGEON STATES THAT THE PATIENT¿S STERNUM OPENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458475 SURGICAL STAINLESS STEEL SUTURE GAQ ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention