BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 3781086 · Received April 30, 2014

    Report

    Report Number
    2210968-2014-05465
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THE SAMPLES WERE VISUALLY AND FUNCTIONALLY EVALUATED AND SAMPLES MET REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HAIR TRANSPLANT PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED ON THE SCALP. ABOUT TWO-THREE WEEKS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED INFLAMMATION IN THE WOUND AREA. THE SUTURE WAS COMING OUT OF THE PATIENT AND WAS NOT BEING ABSORBED. CURRENTLY, THE PATIENT STATUS WAS REPORTED AS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259826 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK DKZ481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention