BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMAHAND-MERSILK SILK SUTURE

    MDR report key: 3771261 · Received April 24, 2014

    Report

    Report Number
    2210968-2014-05255
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ SUTURE NEEDLE PULL OFF OCCURRED. CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 PATIENT UNDERWENT AN UNKNOWN DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE AND ANOTHER SURGERY HAD TO BE PERFORMED TO REMOVE THE NEEDLE FROM THE PATIENT¿S MUCOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250348 PERMAHAND-MERSILK SILK SUTURE SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK 433039

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention