BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX RIGID FOLD PY 14X10 W CUTX1

    MDR report key: 4232619 · Received November 6, 2014

    Report

    Report Number
    9615742-2014-00332
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 14, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PT HAD INGUINAL MESH (B)(4) PLACED IN THE PRE PERITONEAL SPACE FOR HERNIA REDUCTION ON (B)(6) 2014. THE MESH WAS THEN FIXATED USING AN ABSORBATACK DEVICE. THE PATIENT THEN PRESENTED TO DR (B)(6) LAST MONTH AND WAS SCOPED FOR PR BLEEDING AS A RESULT OF AN UNRELATED ISSUE. DURING THE SCOPE DR (B)(6) HAS NOTED THE MESH HAS MIGRATED INTO THE ASCENDING COLON. IT IS UNKNOWN HOW THE MESH HAS MIGRATED TO THIS AREA. THE PATIENT HAS BEEN SENT BACK TO HIS INITIAL TREATING SURGEON FOR HEMICOLECTOMY FOR MESH/BOWEL REMOVAL. DR (B)(6) HAS NOT PROVIDED DETAILS OF TREATING SURGEON OR HOSPITAL WHERE SURGERY TOOK PLACE. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715269 PARIETEX RIGID FOLD PY 14X10 W CUTX1 PARIETEX RIGID FOLD FTL SOFRADIM PRODUCTION TECR1410DP2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other