BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 2860753 · Received December 6, 2012

    Report

    Report Number
    2210968-2012-07935
    Event Type
    Injury
    Date Received
    December 6, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH ECB769 MFG DATE: 03/01/2012, EXP DATE: 01/31/2017,BATCH EDP116 MFG DATE: 04/01/2012, EXP DATE: 01/31/2017.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-07936, 2210968-2012-07937, AND 2210968-2012-07938. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RE-OPERATION DUE TO DEHISCENCE OF THE FEMORAL ARTERY FOLLOWING A STENT PLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED BLEEDING FROM THE ARTERY AGAIN AND REQUIRED ANOTHER SURGERY TO REPAIR THE VESSEL. THE PATIENT WAS ALSO GIVEN CRYSTAL VIOLET TO PREVENT (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention