BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE 1.0M 90CM W/NDL

    MDR report key: 8663290 · Received June 3, 2019

    Report

    Report Number
    2210968-2019-82253
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE NAME OF THE PROCEDURE? PHYSICIAN DOESN`T REMEMBER SPECIFIC PROCEDURE. WHAT IS THE SPECIFIC NUMBER OF DEVICES (TOTAL QTY INVOLVED) THAT FAILED DURING THIS ONE PROCEDURE? 5 EACHES REF W8830 LOTS MGH475; MLA195.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS REMOVED FROM SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457026 PROLENE BLUE 1.0M 90CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. MGH475

    Patients

    Seq Age Sex Outcome Treatment
    1