BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 2180549 · Received July 27, 2011

    Report

    Report Number
    2210968-2011-00998
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE DEVICES WERE VISUALLY AND FUNCTIONALLY INSPECTED FOR KNOT AND STRAIGHT PULL AND MET REQUIREMENTS. THE DEVICES WERE RECEIVED IN A CONDITION THAT MEET SPECIFICATION. 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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UPPER EYELID PLASTIC SURGICAL PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE PATIENT EXPERIENCED SECONDARY BLEEDING AND RETURNED TO THE PHYSICIAN ON (B)(6) 2011 AND WAS FOUND TO HAVE A BROKEN SUTURE. THE PATIENT UNDERWENT REOPERATION ON (B)(6) 2011. CURRENTLY, THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA CMB220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention