BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2193344 · Received July 26, 2011

    Report

    Report Number
    1213643-2011-00357
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 7, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO MEDICAL RECORDS HAVE BEEN PROVIDED, NO SPECIFIC DEVICE FAILURE HAS BEEN ALLEGED AND NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. WITH THE INFORMATION PROVIDED, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON INFORMATION REPORTED TO DAVOL: (B)(6), 2008 - PATIENT UNDERWENT GASTRIC BYPASS. A PREVIOUS MESH WAS REMOVED. A COMPOSIX KUGEL WAS IMPLANTED. DRAINS WERE PLACED AT THE TIME OF THE IMPLANT. (B)(6), 2011 - PATIENT ADMITTED TO THE HOSPITAL PRESENTING WITH ABDOMINAL PAIN AND EPIGASTRIC TUMORATION JUST BELOW THE SCAR. TREATMENT WAS COLLECTION DRAINAGE AND THERAPY. (B)(6), 2011 - THE MESH WAS REMOVED VIA LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC. HURH0429

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention