BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 1882594 · Received October 22, 2010

    Report

    Report Number
    1213643-2010-00455
    Event Type
    Injury
    Date Received
    October 22, 2010
    Report Date
    August 2, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AND WAS SUMMARY REPORTABLE (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFO RECEIVED. WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL; PT, EVENT AND DEVICE'S INFO DAVOL HAS RECEIVED TO DATE. THE MEDICAL RECORDS FOR THE PROCEDURE ON (B)(6)2010, NOTES A "PROLENE" MESH WAS EXPLANTED. IT IS UNCLEAR WHICH MESH THIS IS, AS THE PROVIDED MEDICAL RECORDS INDICATE MULTIPLE HERNIAS/ABDOMINAL SURGERIES THAT WERE PERFORMED PRE AND POST THE IMPLANT OF THE BARD MESH ON (B)(6)2007. NO MEDICAL RECORDS. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: (B)(6)2007 - PT UNDERWENT REPAIR OF A VENTRAL/INCISIONAL HERNIA. BASED ON THE IMPLANT OPERATIVE NOTE, PT'S HERNIA WAS REPAIRED WITH A BARD SMALL DUAL LAYERED COMPOSIX KUGEL MESH PRODUCT. THE EXACT PRODUCT AND LOT# WERE NOT INCLUDED IN THE OPERATIVE REPORT AND ARE CURRENTLY UNK. ON (B)(6)2008 - PT UNDERWENT SURGERY TO REPAIR A BOWEL OBSTRUCTION. PT WENT INTO A COMA DURING THE COURSE OF THE SURGERY. SHORTLY AFTER COMING OUT OF THE COMA, PT WAS INFORMED BY HIS PHYSICIAN THAT THE MESH CONTRIBUTED TO HIS COMPLICATIONS AND INJURY. PT HAS SINCE UNDERGONE AND CONTINUES TO UNDERGO ADDITIONAL SURGERIES TO REMOVE PIECES OF THE COMPOSIX KUGEL MESH, WHICH HAVE CAUSED INJURY AND INFECTION. PER PROVIDED MEDICAL RECORDS: (B)(6)2007 - REPAIR OF LEFT INCISIONAL HERNIA WITH VENTRALEX HERNIA PATCH. PER OPERATIVE NOTE, PT HAS HAD PRIOR HERNIAS TO THIS PROCEDURE REPAIRED WITH MESH. ON (B)(6)2009 - ABDOMINAL WALL RECONSTRUCTION WITH COMPONENT SEPARATION AND BRIDGE WITH NON BARD BIOLOGIC MESH, LYSIS OF ADHESIONS, TAKE DOWN OF ENTEROCUTANEOUS FISTULA, ABDOMINAL WALL DEBRIDED WITH EXCISION OF THE SEPTIC AREAS EMANATING FROM THE MESH AND A PORTION OF THE MESH. ON (B)(6)2009 - PT PAIN SINCE (B)(6)2009 PROCEDURE. ABDOMINAL WALL RECONSTRUCTION WITH UNDERLAY ALLODERM, LYSIS OF ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE MESH, AND CORRECTION OF LOCALIZED FISTULA FROM THE SKIN ENTERING THE SMALL BOWEL. ON (B)(6)2009 - PT COMPLAINS OF LOW GRADE FEVER. ON (B)(6)2010 - EXPLORATION OF LOWER ASPECT OF THE ABDOMINAL SCAR AND REMOVAL OF THE PROLENE SUTURES AS WELL AS "OLD PROLENE" MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FPD429

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R