BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ABSORBATACK

    MDR report key: 8801042 · Received July 17, 2019

    Report

    Report Number
    1219930-2019-04199
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    May 1, 2012
    Report Date
    October 8, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE LAPAROSCOPIC INCISIONAL AND VENTRAL HERNIA REPAIR (LIVHR) WITH PARIETEX COMPOSITE MESH SOURCE MINIMALLY INVASIVE THERAPY VOLUME 21, 2012 (173¿180). (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC EVALUATION OF A LITERATURE STUDY OF ONE DEVICE. A VISUAL INSPECTION OF THE RETURNED P HOTO NOTED THE MESH FIXATION INTO THE ABDOMINAL WALL WITH THE INSTRUMENT. ONLY THE TIP OF THE INSTRUMENT WAS NOTED. NO VISUAL ABNORMALITIES WERE NOTED IN THE PHOTOGRAPH. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RECEIVED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY PERFORMED BETWEEN JANUARY 2007 AND NOVEMBER 2010 87 PATIENTS WERE ADMITTED WITH THE DIAGNOSIS OF ABDOMINAL WALL HERNIA AND UNDERWENT LAPAROSCOPIC INCISIONAL AND VENTRAL HERNIA REPAIR. THE MESH WAS ANCHORED TO THE ABDOMINAL WALL AND FIXED WITH CIRCUMFERENTIAL APPLICATION TACK APPLIERS.THERE WAS A INTRA-OPERATIVE COMPLICATION IN WHICH 1 PATIENT HAD A BLEEDING OF THE ABDOMINAL WALL. EARLY POSTOPERATIVE COMPLICATIONS FOR 6 PATIENTS INCLUDE SEROMA, TROCAR SITE INFECTION AND ABDOMINAL WALL ECCHYMOSES. LATE POSTOPERATIVE COMPLICATION WHICH WAS OBSERVED AT FOLLOW UP FOR 8 PATIENTS WERE 6 HAD SEROMA 1 HAD PERSISTENT HEMATOMA AND 1 HAD PERSISTENT ABDOMINAL PAIN. 3 PATIENTS HAD OPEN REPAIR CONVERSION DUE TO 2 OF THEM HAD MULTIPLE ENDOABDOMINAL ADHESIONS AND 1 HAD UTERINE FIBROMYOMATOSIS. 2 PATIENTS HAD HERNIA RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594061 UNKNOWN ABSORBATACK STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ABSORBATACK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R