BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 3082960 · Received April 23, 2013

    Report

    Report Number
    1213643-2013-00169
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    September 14, 2011
    Report Date
    April 4, 2013
    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
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. WE HAVE, HOWEVER, CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO. ADDITIONALLY, NO SAMPLE HAS BEEN RETURNED FOR EVAL. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE, IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2005 - PATIENT WAS IMPLANTED WITH A BARD PERFIX PLUG. ON (B)(6) 2011, PATIENT UNDERWENT EXPLANT OF MESH. THE ATTORNEY'S REPORT ALLEGES PAIN, PERMANENT INJURY, DEFECTIVE MESH, EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173924 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DPD194

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability