BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1238697 · Received November 19, 2008

    Report

    Report Number
    1213643-2008-00516
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    August 11, 2007
    Report Date
    October 24, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE. REFER TO MDR 1213643-2008-00515 FOR INFORMATION RELATED TO THE COMPOSIX MESH IMPLANTED IN 2004. REFER TO MDR 1213643-2008-00516 FOR INFORMATION RELATED TO THE CATALOG NUMBER 0123810 COMPOSIX E/X MESH IMPLANTED IN 2006. REFER TO MDR 1213643-2008-00517 FOR INFORMATION RELATED TO THE CATALOG NUMBER 0123680 COMPOSIX E/X MESH IMPLANTED THE SAME DAY.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2004 - PT HAD A VENTRAL HERNIA REPAIR WITH IMPLANT OF A COMPOSIX MESH. AFTER SURGERY, PT REPORTS CHRONIC ABDOMINAL PAIN AND CHRONIC POSTOPERATIVE WOUND INFECTION AND DRAINAGE. PT WAS TREATED WITH HOME HEALTH AND IV ANTIBIOTICS. AFTER MONTHS OF TREATMENT THE INFECTION AND PAIN DID NOT SUBSIDE. IN 2005 - PT PLACED ON DISABILITY DUE TO CHRONIC ABDOMINAL PAIN AND PHYSICAL RESTRICTIONS. ON SEVEN MONTHS LATER - PT ADMITTED FOR SURGERY. CT SCAN REVEALED A VERY LARGE INFECTION ALONG A PROGRESSIVE ABSCESS FORMATION. DIAGNOSED WITH CHRONIC INCARCERATION, INFECTED MESH AND LOCALIZED ABSCESS. MESH EXPLANTED AND REPAIRED THE RECURRENT VENTRAL INCISIONAL HERNIAS. ON FIVE DAYS LATER - PT DISCHARGED. IN 2006 - PT ADMITTED FOR ACUTE MECHANICAL SMALL BOWEL OBSTRUCTION AND RECURRING HERNIA. PT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH IMPLANT OF TWO COMPOSIX E/X PATCHES (CATALOG #S 0123810 AND 0123680.) ON THE NEXT DAY - PT WAS DISCHARGED. IN 2007 - PT REPORTED ONSET OF ABDOMINAL PAIN, NAUSEA AND VOMITING. ON THE NEXT DAY - PT ADMITTED AND CT SCAN REVEALED THAT ONE OR MORE OF THE PATCHES HAD PULLED AWAY FROM THE MUSCLES AND THE SMALL INTESTINE HAD CREPT IN THE SUBCUTANEOUS FAT. PT UNDERWENT IV HYDRATION, PAIN, NAUSEA CONTROL AND NG TUBE SUCTION. THREE DAYS LATER - PT DISCHARGED FROM THE HOSPITAL. ON THE FOLLOWING MONTH - PT WAS ADMITTED FOR EVALUATION OF NAUSEA AND EXTREME VOMITING AND DIAGNOSED WITH A RECURRENT SMALL BOWEL OBSTRUCTION. THE PT WAS CONSERVATIVELY TREATED. ON TWO DAYS LATER - PT DISCHARGED. PT'S PHYSICIAN INDICATED MESH PATCHES NEED TO BE EXPLANTED AS SOON AS SHE OBTAINS MEDICAL INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43IPD284

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R