BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFIX PLUG

    MDR report key: 1700945 · Received May 19, 2010

    Report

    Report Number
    1213643-2010-00229
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    October 4, 2008
    Report Date
    April 21, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MEDICAL RECORDS PROVIDED, IT IS NOT CLEAR WHAT THE PT'S CLINICAL COURSE WAS BEYOND (B) (6) 2008 WHEN SHE WAS DISCHARGED FROM THE HOSPITAL AND APPARENTLY TRANSITIONED TO ANOTHER FACILITY FOR CONTINUED REHAB UP THROUGH HER DEATH. THE INFO FROM THE PROVIDED MEDICAL RECORDS, AND FURTHER SUPPORTED BY THE PHOTOGRAPHS OF ABDOMINAL INCISIONS AND WOUNDS, INDICATES THE POST MESH IMPLANT MEDICAL AND SURGICAL PROCEDURES WERE LOCATED AT THE ABDOMINAL MIDLINE AND BELOW THE MIDLINE, AND WERE NOT ASSOCIATED WITH THE UPPER MIDLINE WHERE THE BARD PERFIX PLUG WAS IMPLANTED. THE MEDICAL RECORDS PROVIDED DID NOT INCLUDE A STATEMENT OR INDICATION THAT THERE WAS A POSSIBLE OR SUSPECTED DEVICE FAILURE RELATED TO THE BARD PERFIX PLUG MESH. ADDITIONALLY, THERE IS NO INDICATION THAT THE BARD PERFIX PLUG WAS EXPLANTED. NO SAMPLE HAS BEEN RETURNED FOR EVAL; HOWEVER, BASED ON THE CURRENTLY AVAILABLE INFO, THERE IS NO INDICATION THE BARD PERFIX PLUG MESH CAUSED OR CONTRIBUTED TO THE PT'S INFECTION OR DEATH. FOR ADD'L CLINICAL DETAIL AND INFO RELATED TO THE COMPOSIX E/X MESH, SEE MDR 1213643-2008-00366.

    Description of Event or Problem · 1

    INFORMATION REPORTED VIA MAUDE EVENT REPORT: PT'S DAUGHTER REPORTED PT EXPERIENCED PAIN, NAUSEA, SEVERE WEAKNESS, ELEVATED WHITE BLOOD CELL COUNT, INFECTED MESH, SEVERE RECTAL BLEED, FISTULAS, AND BOWEL SURGERIES WITH AN ILEOSTOMY, SEPSIS AND DEATH FOLLOWING THE MESH IMPLANT SURGERY. MEDICAL RECORD INFO: (B) (6) 2007 - HERNIA REPAIRS WITH 2 BARD MESH IMPLANTS. (UPPER MIDLINE) SEPRAFILM WAS IMPLANTED PRIOR TO PERFIX PLUG. (LOWER MIDLINE) SEPRAFILM WAS IMPLANTED OVER THE SMALL BOWEL PRIOR TO BARD COMPOSIX E/X MESH. ON (B) (6) 2008 - EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, EXTENDED RIGHT HEMICOLECTOMY FOR A MASSIVE LOWER GI BLEED NOTED TO BE RELATED TO ANGIODYSPLASIA. PER OR NOTES: MESH PRESENT AND PRESERVED. TWO SHEETS SEPRAFILM IMPLANTED IN PERITONEAL CAVITY. PT DEVELOPED WOUND INFECTION, ABSCESS, AND COLOCUTANEOUS FISTULA DUE TO AN ANASTOMOTIC DEHISCENCE. ON (B) (6) 2008: WOUND PACKING FOR ABDOMINAL WOUND INFECTION. ON (B) (6) 2008: EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, DRAINAGE OF INTRA-ABDOMINAL COLLECTION, PLACEMENT OF LOOP ILEOSTOMY. FISTULA DRAINAGE DECREASED, BUT, RESULTED IN INFECTION OF MESH. ON (B) (6) 2008 - DRAINAGE OF THE ABSCESS, CLOSURE OF THE FISTULA, PARTIAL MESH EXPLANT (COMPOSIX EX MESH). PER OPERATING ROOM REPORT, MESH WAS CLEARLY INFECTED AS A RESULT OF THE ANASTOMOTIC DEHISCENCE IN THE PAST. PT BEGAN HAVING BILIOUS DRAINAGE FROM THE MIDLINE INCISION; FINDINGS CONSISTENT WITH AN ENTEROCUTANEOUS FISTULA. ON (B) (6) 2008: THE PT UNDERWENT LAPAROTOMY, WOUND EXPLORATION, AND DEBRIDEMENT, CLOSURE OF THE COLOCUTANEOUS FISTULA. ON (B) (6) 2008 - PT DIED. PER DEATH CERTIFICATE, IMMEDIATE CAUSE OF DEATH WAS SEPSIS SYNDROME, WITH SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH LISTED AS LIVER FAILURE AND SACRAL DECUBITI. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43KQD161

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H