BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2445737 · Received February 7, 2012

    Report

    Report Number
    1213643-2012-00084
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    April 20, 2006
    Report Date
    March 6, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARCH, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0760-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S ATTORNEY INITIAL REPORTED A SINGLE COMPOSIX KUGEL MESH, WHICH WAS FILED WITH THE FDA UNDER (B)(4) WHEN DAVOL WAS ORIGINALLY MADE AWARE OF THE COMPLAINT. HOWEVER, MEDICAL RECORDS WERE LATER RECEIVED THAT IDENTIFIED AN ADDITIONAL MESH. CURRENTLY IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE MEDICAL RECORDS NOTE THAT THE PT HAD A PERFORATED SMALL BOWEL THAT HAD WALLED OFF AN ABSCESS UP AGAINST THE MESH, HOWEVER, IT DOT NOT INDICATE THE CAUSE OF BOWEL PERFORATION OR ABSCESS. THE PT REPORTEDLY DEVELOPED ADHESIONS WHICH IS LISTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED PAIN AND SEVERE INJURIES AFTER THE IMPLANT OF A COMPOSIX KUGEL MESH. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2005 - THE PT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY AND OPEN REPAIR OF A VENTRAL HERNIA WITH TWO COMPOSIX KUGEL MESHES. ON (B)(6) 2006 - HOSPITALIZED WITH SORENESS AROUND UMBILICUS AND FEVER, ADMITTED FOR INTER-LOOP ABSCESS, IV ANTIBIOTIC TREATMENT, SUBFASCIAL FLUID COLLECTION WITH ULTRASOUND GUIDANCE. ON (B)(6) 2006 - HOSPITALIZED, FOUND TO HAVE FLUID COLLECTION WITH PERFORATED SMALL BOWEL THAT HAD WALLED OFF AN ABSCESS UP AGAINST THE MESH. ON (B)(6) 2006 - THE PT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, EXCISION OF BOTH COMPOSIX KUGEL MESHES, PARTIAL SMALL BOWEL RESECTION, ADVANCEMENT FLAB, CLOSURE OF ABDOMEN AND INSERTION OF SURGI-WRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARCH, INC. 43CPD327

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R