BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE

    MDR report key: 3023569 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02989
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K001625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. IT COULD NOT BE DETERMINED IF THE ABRASION DAMAGE OCCURRED AFTER THE PRODUCT WAS DISPENSED, OR WAS PRESENT WHEN THE PRODUCT WAS INITIALLY OPENED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS NOTED THAT THE SUTURE WAS BROKEN. THIS OCCURRED PRIOR TO USE ON THE PATIENT. THEREFORE THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125744 PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE SUTURE, NON ABSORBABLE GAQ ETHICON, INC. NA EJR280

    Patients

    Seq Age Sex Outcome Treatment
    1