BEUDAMED
    FDA Adverse Event Summary report: N

    VENTRALEX ST

    MDR report key: 3042745 · Received April 2, 2013

    Report

    Report Number
    1213643-2013-00131
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON REPORTS THE PT DEVELOPED AN ALLERGIC REACTION FOLLOWING THE IMPLANT OF A VENTRALEX ST MESH. CURRENTLY, ALLERGY TESTING HAS NOT BEEN CONDUCTED. A REVIEW OF THE MFG RECORDS WAS PERFORMED INCLUDING A REVIEW OF STERILITY RECORDS AND THERE WAS NO EVIDENCE OF A MFG 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 INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER SALES REP AND THE SURGEON: IT WAS ALLEGED THAT THE PT WAS IMPLANTED WITH THE VENTRALEX ST MESH AND HAD A POST-OP REACTION. THE SURGEON FELT IT MAY HAVE BEEN DUE TO CELLULITIS. THE PT WAS TREATED WITH ANTIBIOTICS, AND THE AREA HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134395 VENTRALEX ST FTL DAVOL INC. NA HUWC0194

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention