BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 4223173 · Received November 4, 2014

    Report

    Report Number
    2210968-2014-15267
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 A PATIENT UNDERWENT A MICRO-LAMINECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED TO CLOSE THE INCISION. THE PATIENT RETURNED WITH A WOUND DEHISCENCE AND INFECTION. AN INCISION AND DRAINAGE PROCEDURE WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705409 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention