BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2031101 · Received March 16, 2011

    Report

    Report Number
    1213643-2011-00079
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    January 11, 2011
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT FROM PATIENT'S ATTORNEY INDICATED ONE BARD MESH WAS IMPLANTED ON (B)(6) 2003. RECEIPT OF OPERATIVE IMPLANT REPORT ON (B)(6) 2011 INDICATED A SECOND MESH WAS ALSO IMPLANTED ON (B)(6) 2003; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFORMATION RECEIVED. SEE MDR 1213643-2010-00391 FOR INFORMATION RELATED TO THE FIRST PERFIX PLUG IMPLANTED ON (B)(6) 2003. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THE PROVIDED IMPLANT OPERATIVE REPORT DID NOT INCLUDE A STATEMENT OR INDICATION THAT THERE WAS A POSSIBLE OR SUSPECT DEVICE FAILURE RELATED TO THE BARD MESH. A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: PATIENT SUFFERS FROM A BILATERAL INGUINAL HERNIA IN THE GROIN ON THE RIGHT SIDE WITH A SLIDING HERNIA. ON (B)(6) 2003: PATIENT WAS IMPLANTED WITH THE LARGE BARD MESH PERFIX PLUG DURING SURGERY. AS A DIRECT AND PROXIMATE RESULT OF THE IMPLANT OF BARD MESH PERFIX PLUG, PATIENT WAS CAUSED TO SUFFER PHYSICAL INJURIES. AS A RESULT, PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND SUFFERED EXTENSIVE COMPLICATIONS ARISING FROM THE INSERTION OF THE PRODUCT. AS A RESULT, PATIENT SUFFERED SEVERE INJURY THAT IS CONTINUING IN NATURE AND REQUIRES MEDICAL MONITORING AND CARE. PER PROVIDED MEDICAL RECORDS: ON (B)(6) 2003: BILATERAL INGUINAL HERNIA REPAIR WITH MESH IMPLANTS. HERNIAS IN GROIN, RIGHT SIDE, WITH SLIDING HERNIA. PT HAD DIRECT HERNIA ON RIGHT HERNIA SAC. TWO MESH PLUGS USED TO OCCUPY THE DEFECT WITHIN THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CND354

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention