BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 3041989 · Received April 2, 2013

    Report

    Report Number
    1213643-2013-00130
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K101928
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON REPORTS THE PATIENT DEVELOPED AN ALLERGIC REACTION FOLLOWING THE IMPLANT OF A VENTRALEX ST MESH. CURRENTLY, ALLERGY TESTING HAS NOT BEEN CONDUCTED; HOWEVER, IT WAS SINCE REPORTED THE REACTION RESOLVED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED INCLUDING A REVIEW OF STERILITY RECORDS AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. ADDITIONALLY, ALLERGIC REACTION IS LISTED AS A KNOWN ADVERSE EVENT IN THE PRODUCT'S IFU. THE MESH REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE SURGEON: IT WAS ALLEGED THAT THE PATIENT WAS IMPLANTED WITH THE VENTRALEX ST MESH AND HAD A POST OP REACTION. THE SURGEON FELT IT MAY HAVE BEEN DUE TO CELLULITIS. THE PATIENT HAS BEEN STARTED ON ANTIBIOTICS AND THE REACTION HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134165 VENTRALEX ST FTL DAVOL INC. NA HUWK0929

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention