BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 2970205 · Received February 20, 2013

    Report

    Report Number
    2210968-2013-01467
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    December 26, 2017
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL DISCHARGE, ABNORMAL MENSTRUAL BLEEDING, DYSPAREUNIA, PELVIC PRESSURE, AND URINARY INCONTINENCE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 BY DR. (B)(6), AND (B)(6) 2011 BY (B)(6) DUE TO MESH EXPOSURE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DISCOMFORT WITH INTERCOURSE, FREQUENCY, DRIBBLING, PELVIC PRESSURE, VAGINAL DISCHARGE, VAGINAL SPOTTING, ABNORMAL MENSTRUAL BLEEDING, DYSPAREUNIA, AND URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT UNDERWENT MESH REVISION (CORRECTION MADE IN OPERATION PERFORMED) ON (B)(4) 2009 BY DR. (B)(6) MD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DISCOMFORT WITH INTERCOURSE, FREQUENCY, DRIBBLING, PELVIC PRESSURE, VAGINAL DISCHARGE, VAGINAL SPOTTING, ABNORMAL MENSTRUAL BLEEDING, DYSPAREUNIA, AND URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73858 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3270162

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention