BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 3925635 · Received June 27, 2014

    Report

    Report Number
    1213643-2014-00205
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 5, 2014
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENTLY AVAILABLE INFO WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS ALLEGED. A MFG REVIEW WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. A MESH SAMPLE IS BEING PROVIDED TO THE DOCTOR FOR REACTIVITY RESPONSE TESTING. WHEN/IF THE RESULTS OF THE REACTIVITY TESTING ARE PROVIDED TO DAVOL, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: IT WAS REPORTED THAT IN 2005 THE PT WAS IMPLANTED WITH A BARD PERFIX PLUG. CONTACT REPORTS THAT THE PT HAD SEVERAL CONSTITUTIONAL PROBLEMS AND A SKIN REACTION FOR A LONG TIME. SYMPTOMS HAVE INCREASED AND THE DOCTOR WOULD LIKE A SAMPLE FOR REACTIVITY TESTING TO DETERMINE IF THE PT MAY BE ALLERGIC TO POLYPROPYLENE. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376912 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43BPD087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention