BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS CORD

    MDR report key: 2903652 · Received January 9, 2013

    Report

    Report Number
    2210968-2013-00144
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 16, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. ACTUAL SAMPLE IS A CORD WITH ONE NEEDLE STILL ATTACHED AND ONE LOOSE, USED NEEDLE. THE DETACHED END OF THE CORD SHOWS ONLY POOR SWAGING MARKS WHICH PROBABLY CAUSED THE NEEDLE DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REPAIR OF THE ACHILLES TENDON ON (B)(6) 2012, AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE PULLED OFF THE SUTURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12806 PDS CORD SUTURE, ABSORBABLE GAN ETHICON, INC. NA EH8BKXD0

    Patients

    Seq Age Sex Outcome Treatment
    1