BEUDAMED
    FDA Adverse Event Other Summary report: N

    KUGEL PATCH

    MDR report key: 2358208 · Received November 30, 2011

    Report

    Report Number
    1213643-2011-00692
    Event Type
    Other
    Date Received
    November 30, 2011
    Date of Event
    September 11, 2008
    Report Date
    April 22, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 2008004. SUBSEQUENTLY, DAVOL HAS RECEIVED ADD'L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADD'L INFO RECEIVED. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE MEDICAL RECORDS PROVIDED DO NO EXTEND BEYOND THE IMPLANT OF THE MESH AND DO NO INDICATE A DEVICE FAILURE. THE PT'S ATTORNEY ALLEGES THAT THE MESH "FOLDED UP ON ITSELF". HOWEVER NO SAMPLE HAS BEEN RETURNED FOR EVAL AND NO LOT NUMBER HAS BEEN PROVIDED TO PERFORM A SPECIFIC MFG REVIEW. WE HAVE CONTACTED THE INITIAL REPORTER TO OBTAIN ADD'L INFO AND TO HAVE THE DEVICE RETURNED. WITH THE INFO PROVIDED, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2004, REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH COMPOSIX KUGEL MESH. PER ATTORNEY'S REPORT: IN (B)(6) 2008, THE PT BEGAN TO EXPERIENCE SEVERE ABDOMINAL PAIN AS WELL AS ABDOMINAL TENDERNESS AND DISTENTION. OVER TIME THE PAIN AND OTHER COMPLICATIONS GREW IMMENSELY WORSE. THE PT SOUGHT MEDICAL TREATMENT. THE PT CONSULTED WITH HER PHYSICIAN WHO DIAGNOSED THE MESH PATCH IMPLANTED AS THE CAUSE OF THE PT'S SUFFERING. ON (B)(6) 2008, THE PT UNDERWENT SURGERY TO REMOVE THE MESH PATCH. THE OPERATIVE REPORT STATED THAT THE MESH WAS "FOLDED UP ON ITSELF." THE MESH WAS EXPLANTED AND REPLACED WITH ANOTHER TYPE OF MESH PATCH. DUE TO THE INFECTION MESH PATCH, THE PT HAD TO SUFFER FROM THE EXTREME PAIN, HOSPITALIZATION AND MENTAL ANGUISH.

    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 37 YR Hospitalization| R