BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 4590810 · Received March 11, 2015

    Report

    Report Number
    2210968-2015-02778
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    November 22, 2014
    Report Date
    February 16, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF TWO PIECES OF ONE STRAP WAS PERFORMED. THE EVALUATION CANNOT DETERMINE IF THE STRAP SAMPLE WAS OR WAS NOT EXPOSED TO A HIGH TEMPERATURE, HEATING CONDITION OR OTHER RADIATION EXPOSURE. IN ADDITION, IF STRAP WAS BROKEN OR CUT, IT HAS NOT BEEN ATTRIBUTED TO MANUFACTURING OR PACKAGING PROCESS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR WITH LAPAROSCOPIC TAPP TECHNIQUE ON (B)(6) 2014. THE PATIENT EXPERIENCED RECURRENCE ON (B)(6) 2014. THE PATIENT WAS DOING NORMAL DAILY ACTIVITIES AND REPORTED THE SOUND OF THE BREAKING AND THAT SOMETHING NOT NORMAL WAS HAPPENING. WHEN THE PATIENT FELT THE STRANGE FEELING OF MESH MIGRATION, THE PATIENT WENT BACK TO THE SURGEON WHO OPINED IT WAS RECURRENCE. THE PATIENT UNDERWENT RE-OPERATION ON (B)(6) 2014 AND THE STRAPS WERE FOUND BROKEN. THE PATIENT REPORTS NO FURTHER COMPLAINTS FOLLOWING THE RE-OPERATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED TO FIXATE MESH. THE STRAPS BROKE INSIDE THE PATIENT AND THE PATIENT EXPERIENCED A HERNIA RECURRENCE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168667 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. UNK GKZ596

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention