BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1222107 · Received November 5, 2008

    Report

    Report Number
    2210968-2008-01090
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/05/2008. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A VASCULAR STENT. THE PATIENT DEVELOPED VASCULAR BLEEDING AND A HEMATOMA THE FOLLOWING DAY. THE PATIENT'S CONDITION CONTINUED TO DETERIORATE, ACCORDINGLY, THE PATIENT WAS SUBSEQUENTLY RETURNED TO SURGERY. THE OPERATING SURGEON OBSERVED AN INSUFFICIENT ANASTOMOSIS BECAUSE THE SUTURE BROKE. THE ANASTOMOSIS WAS REPAIRED AND THE PATIENT IS REPORTED AS "WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA AGE658

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention