BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE UNKNOWN

    MDR report key: 4113716 · Received September 24, 2014

    Report

    Report Number
    2210968-2014-13660
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. INTRA-OPERATIVELY, THE NEEDLE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595428 SUTURE UNKNOWN GAP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1