BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 2972831 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01377
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 AND EVALUATED. THE NEEDLE IS PROTRUDING THROUGH THE OVERWRAP POUCH RESULTING IN HOLE IN THE OVERWRAP PACKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2013 AND SUTURE WAS USED. WHILE PREPARING FOR THE SURGERY, IT WAS NOTED THAT THE NEEDLE WAS STICKING OUT OF THE PACKAGE. THIS OCCURRED PRIOR TO USE ON THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75523 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA EKR138

    Patients

    Seq Age Sex Outcome Treatment
    1