BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO ST

    MDR report key: 3252237 · Received July 24, 2013

    Report

    Report Number
    1213643-2013-00319
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 3, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101920
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT FOLLOWING IMPLANT THE PATIENT DEVELOPED A RASH ALL OVER HER BODY WITH SWELLING OF THE UPPER EXTREMITIES. ALLERGIC REACTION IS IDENTIFIED AS A KNOWN POSSIBLE ADVERSE REACTION IN THE PRODUCTS IFU. IT WAS ALSO REPORTED THAT THE PATIENT'S SYMPTOMS RESOLVED FOLLOWING EXPLANT OF THE DEVICE. MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE REQUESTED ADDITIONAL INFORMATION FROM THE PATIENT'S SURGEON INCLUDING SAMPLE STATUS AND AVAILABILITY. A MANUFACTURING REVIEW WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/ OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PATIENT'S SURGEON: DATE (B)(6) 2013, PATIENT WAS IMPLANTED WITH A VENTRIO ST MESH DURING AN UMBILICAL HERNIA REPAIR. DATE (B)(6) 2013, PATIENT CALLED SURGEON'S OFFICE COMPLAINING OF ITCH, RASH AND SWELLING OF HER EXTREMITIES AND REQUESTING THE MESH BE REMOVED. DATE (B)(6) 2013, PATIENT WAS SEEN IN THE OFFICE AND A RASH WAS NOTED BY SURGEON, ALONG WITH SWELLING OF THE PATIENT'S HANDS AND FEET. PATIENT HAD REFUSED TO TAKE POST-OP PAIN MEDICATION, AS WELL AS THE PREDNISONE PRESCRIBED FOR HER RASH. THE SURGEON NOTED IN HER OFFICE NOTES THAT SHE DID NOT FEEL THE PATIENT'S SYMPTOMS WERE DEVICE RELATED; HOWEVER "AT THE PATIENT'S INSISTENCE I WILL REMOVE THE MESH". DATE (B)(6) 2013, PATIENT HAD THE MESH EXPLANTED. SURGEON NOTED NO REDNESS OR INFLAMMATION IN THE TISSUE SURROUNDING THE MESH DURING EXPLANT. WITHIN TWO TO THREE HOURS AFTER THE MESH WAS EXPLANTED, THE PATIENT STATED HER SYMPTOMS WERE RESOLVED AND THE RASH AND SWELLING WERE NOTED TO IMPROVE. FOLLOWING THE INITIAL CONTACT WITH THE PATIENT'S SURGEON DAVOL RECEIVED A LETTER FROM THE PATIENT WHICH WAS ADDRESSED TO THE FDA. THE LETTER DESCRIBES SYMPTOMS OF AN ALLERGIC REACTION AND STATES THAT THE SYMPTOMS RESOLVED FOLLOWING EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344426 VENTRIO ST FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXB0574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention