BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 3771128 · Received April 24, 2014

    Report

    Report Number
    2210968-2014-05251
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 A LAPAROSCOPIC IPOM INCISIONAL HERNIA REPAIR PROCEDURE AND ABSORBABLE STAPLES WERE USED TO SECURE THE MESH. APPROXIMATELY TWO WEEKS FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF FLUID AT THE PROCEDURE SITE. THE PATIENT WAS HOSPITALIZED AND 2 LITERS OF FLUID WAS DRAINED FROM THE ABDOMINAL WALL. (B)(6) 2014 A REOPERATION WAS DONE. DURING THE REOPERATION IT WAS NOTED THAT THE ABSORBABLE STAPLES WERE STILL IN THE MESH BUT WITHOUT ANY FIXATION TO THE ABDOMINAL WALL. IT WAS DETERMINED THAT AN E-COLI INFECTION WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249994 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. GJK587

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R