BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2170074 · Received July 13, 2011

    Report

    Report Number
    1213643-2011-00334
    Event Type
    Injury
    Date Received
    July 13, 2011
    Report Date
    March 10, 2008
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH RAE (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFORMATION INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFORMATION RECEIVED. BASED ON A REVIEW OF THE PROVIDED MEDICAL RECORDS, THE PATIENT UNDERWENT A SALPINGO-OOPHORECTOMY AND SIMULTANEOUS VENTRAL HERNIA REPAIR WITH A KUGEL PATCH ON (B)(6) 2005. FEW RECORDS ARE AVAILABLE REGARDING THE PATIENT'S POST-OPERATIVE COURSE. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS WAS TAKEN ON (B)(6) 2005 AFTER REPORTS OF ABDOMINAL PAIN AND SHOWED METALLIC FRAGMENTS IN THE LEFT SIDE OF THE ABDOMEN, BUT WAS OTHERWISE NEGATIVE. ANOTHER CT SCAN ON (B)(6) 2007 SHOWED A SMALL LOW ATTENUATION MASS ON THE POSTERIOR LEFT KIDNEY, LIKELY A SMALL CYST, BUT WAS ALSO OTHERWISE NEGATIVE. CURRENTLY, IT IS UNKNOWN WHETHER, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. WITH THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2004 - DIAGNOSTIC LAPAROSCOPY, RIGHT SALPINGO-OOPHORECTOMY, VENTRAL HERNIA REPAIR WITH A KUGEL PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention ADDITIONAL INFORMATION BASED ON MEDICAL RECORD| NOTE: SEE MEDICAL RECORD REVIEW (ATTACHED) FOR | REVIEW.| TLT RN CNOR (B)(6) 2011| ADDITIONAL INFORMATION BASED ON MEDICAL RECORD| TLT RN CNOR (B)(6) 2011| REVIEW.| NOTE: SEE MEDICAL RECORD REVIEW (ATTACHED) FOR