BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFIX LIGHT PLUG

    MDR report key: 6166335 · Received December 12, 2016

    Report

    Report Number
    1213643-2016-00569
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Report Date
    December 12, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K092032
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER HAVE NOT BEEN RECEIVED TO DATE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT (269 UNITS) WAS MANUFACTURED TO SPECIFICATION, WITH NO ANOMALIES NOTED. NO OTHER COMPLAINTS HAVE BEEN REPORTED TO DATE FOR THIS LOT. WHEN THE SAMPLES ARE RETURNED A SUPPLEMENTAL MDR WILL BE SENT TO DOCUMENT OUR FINDINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BARD/DAVOL BY OUR (B)(6) AFFILIATE THAT DURING THEIR INCOMING INSPECTION TWO PERFIX LIGHT PLUGS WERE IDENTIFIED AS HAVING A POSSIBLE INSUFFICIENT SEAL. THE UNITS ARE BEING RETURNED FOR EVALUATION. AS A POSSIBLE BREACH OF STERILE BARRIER CONDITION WAS ALLEGED TO BE PRESENT AN MDR IS BEING FILED TO DOCUMENT THE CONDITION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816327 PERFIX LIGHT PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUAT2532

    Patients

    Seq Age Sex Outcome Treatment
    1