BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENEMESH

    MDR report key: 3200968 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11837
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    September 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT MESH WAS IMPLANTED ON AN UNSPECIFIED DATE TO TREAT BLADDER PROLAPSE WITH CONCURRENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND VAGINAL COLPOPEXY. IT WAS ALSO REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, INFECTION, BLEEDING AND DIFFICULTY DURING SEX. NO ADDITIONAL INFORMATION WAS PROVIDED.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 02/07/2014. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF MESH ON (B)(6) 2015 BY DR. (B)(6) AT (B)(6) DUE TO EROSION OF MESH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND (B)(6) 2009 AND MESH AND PELIVSOFT MESH WERE IMPLANTED. DATES NOT CLARIFIED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, UTIS AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301673 PROLENE POLYPROPYLENEMESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK AHR341

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention