BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODIFIED KUGEL PATCH

    MDR report key: 5679147 · Received May 25, 2016

    Report

    Report Number
    1213643-2016-00234
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    March 20, 2013
    Report Date
    May 2, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ADDENDUM TO THE PREVIOUS REPORT. THIS SUPPLEMENTAL REPORT IS BEING SENT TO SHOW THAT THE PATIENT WAS IMPLANTED WITH A BARD MODIFIED KUGEL HERNIA PATCH AND NOT A COMPOSIX KUGEL HERNIA PATCH AS WAS ORIGINALLY ALLEGED. THE MEDICAL RECORDS INDICATE THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS AS WELL AS THE MODIFIED KUGEL MESH BECOMING DISLODGED. THE PATIENT UNDERWENT REMOVAL OF THE BARD MODIFIED KUGEL HERNIA PATCH APPROXIMATELY SEVEN YEARS POST IMPLANT. RECURRENCE AND ADHESIONS ARE BOTH LISTED AS POSSIBLE KNOWN ADVERSE REACTIONS IN THE INSTRUCTIONS-FOR-USE. WITH THE CURRENT INFORMATION PROVIDED NO DEFINITIVE CONCLUSION CAN BE MADE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. NOTE: 510K NUMBERS FOR THE MODIFIED KUGEL PATCH ARE K963141/K021736. UPDATED FIELDS: AGE/DATE OF BIRTH, OUTCOMES ATTRIBUTED TO ADVERSE EVENTS, DATE OF EVENT, DESCRIBE PROBLEM OR EVENT, BRAND NAME, MODEL/LOT #, USER FACILITY OR IMPORTER, USER FACILITY OR IMPORTER CONTACT INFO., EVENT PROBLEM CODES, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE MANUFACTURE DATE, ADDITIONAL MFR NARRATIVE. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: PATIENT UNDERWENT HERNIA REPAIR SURGICAL PROCEDURES, AND DURING THE COURSE THEREOF THE HERNIA REPAIR PRODUCT WAS IMPLANTED. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED PAIN AND SUFFERING, INJURY AND WAS SERIOUSLY AND PERMANENTLY INJURED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) - PATIENT UNDERWENT HERNIA REPAIR SURGICAL PROCEDURES, AND DURING THE COURSE THEREOF THE HERNIA REPAIR PRODUCT WAS IMPLANTED. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED PAIN AND SUFFERING, INJURY AND WAS SERIOUSLY AND PERMANENTLY INJURED. ADDENDUM TO THE PREVIOUS REPORT, BASED ON MEDICAL RECORDS RECEIVED ON 07/13/2016 AND PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006 - PATIENT UNDERWENT IMPLANT OF A BARD MODIFIED KUGEL HERNIA PATCH FOR AN UMBILICAL HERNIA REPAIR. ON (B)(6) 2013 - THE PATIENT WAS NOTED TO HAVE A REDUCIBLE, BUT VERY TENDER UMBILICAL/ VENTRAL HERNIA. THE PATIENT UNDERWENT A LAPAROSCOPIC LYSIS OF ADHESIONS, LAPAROSCOPIC EXPLANT OF THE BARD MODIFIED KUGEL PATCH AND LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH. OPERATIVE DICTATION FOR THIS PROCEDURE NOTED THE MODIFIED KUGEL PATCH WAS "PARTIALLY DISLODGED FROM THE ABDOMINAL WALL AND BUNCHED UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333117 MODIFIED KUGEL PATCH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 43EQD185

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention| S