BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 9831847 · Received March 13, 2020

    Report

    Report Number
    1213643-2020-02539
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    December 21, 2009
    Report Date
    March 13, 2020
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE MADE. THE INFORMATION PROVIDED IS LIMITED TO THE MAUDE EVENT REPORT AND ALLEGES THAT SIX AND A HALF YEARS POST IMPLANT OF A BARD PERFIX PLUG (ALLEGED COUNTERFEIT MESH) THE PATIENT UNDERWENT A PARTIAL EXPLANT. THERE IS NO INDICATION AS TO WHY THE MESH WAS EXPLANTED. THERE WAS NO CONTACT INFORMATION PROVIDED, AS SUCH REQUESTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. A LOT NUMBER WAS NOT PROVIDED; WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. WHILE COUNTERFEIT MESH WAS ALLEGED, BD/BARD IS UNAWARE OF ANY COUNTERFEIT PERFIX PLUG MESH HAVING BEEN IN THE MARKET. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT MW5093265: ¿AEROMONAS HYDROPHILA (B)(6) SEAFOOD CHOWDER COUNTERFEIT MESH BY (B)(6). THIS IS AN ADD ON TO THE REPORT I JUST SUBMITTED BECAUSE IT DOES NOT APPEAR THAT YOU TOOK MY EMAIL I SEE (B)(6) WAS THERE WHEN THIS WAS INITIALLY REPORTED. I HAVE NO PROBLEM SAYING HHS/FDA-OIG COVER UP MAKES HIM CULPABLE. REFER TO US DOJ CRIMINAL PROSECUTIONS OR (B)(6). HE PUTS JUDGES IN PRISON TOO. SO DOES (B)(6) (REF, (B)(6). (B)(6) IS LAWYER AND POLITICIAN THAT MAKES THIS FORM NOTHING MORE THAN DATA COLLECTION-HE¿S NOT MY REPRESENTATIVE, MY ADVOCATE AND HIS EDUCATION MAKES HIM EVIL. SO FORWARD TO POTUS AND TELL HIM THIS IS NO DIFFERENT THAN THE TREE OF LIFE SHOOTINGS; I THINK THE SHOOTER IS GETTING DEATH ROW. I EXPECT THE SAME. FDA OIG ALREADY GAVE MY NAME TO MANUFACTURER; RESULTED IN TERRORISTIC THREATS, OBSTRUCTION OF JUSTICE, WITNESS TAMPERING (THREATS TO ME ARE RECORDED AS EVIDENCE) DO NOT DO IT AGAIN OR YOU¿LL SEC OF HHS ALSO BE INCLUDED IN THIS CASE. FOOD (B)(6) SEAFOOD CHOWDER; DEVICE-CR BARD MESH PLUG & PANEL (FALSIFIED). (B)(6) FISH MARKET; CR BARD DAVOL. CASCADE OF DELETERIOUS EFFECTS FROM NO CONSENT COUNTERFEIT MESH; IT¿S AND ENDOCRINE SYSTEM DISRUPTOR. SPINAL CORD INJURY FROM ¿COVER-UP PERPETRATORS.¿ NO PRESCRIPTION MEDS (CAN¿T DIGEST ENTERIC COATINGS); MEDICAL IMPLANT NOT COMPLETELY EXPLANTED (YOUR CRIME; NOT MINE). I BELIEVE YOUR AGENCY IS COPYING ME-YOU HAVE TO PAY FOR IT WHICH IS WHY I EXPECT (B)(6) TO BE INDICTED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293242 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention