BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE* POLYPROP.MESH

    MDR report key: 3191114 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11267
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    January 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, STATUS POST FAILED BLADDER SUSPENSION. FOLLOWING INSERTION, THE PATIENT EXPERIENCED URINARY PROBLEMS AND RECURRENCE.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCONTINENCE, URINARY LEAKAGE, URINARY FREQUENCY, AND INFECTION.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A DEVICE HISTORY REVIEW HAS BEEN INSERTED INTO THE FILE. THIS REVIEW INDICATES THAT THERE WAS NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS. THE MANUFACTURER DATE AND EXPIRATION DATE HAVE BEEN OBTAINED. FILE HAS BEEN UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290735 PROLENE* POLYPROP.MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK MHEV13

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention