BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2973284 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01563
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH VAGINAL HYSTERECTOMY.

    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.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). IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT PELVIC ORGAN PROLAPSE AND MESH WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND A MESH WAS IMPLANTED CONCURRENTLY WITH SACROSPINOUS COLPOPEXY AND PERINEOPLASTY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL BLEEDING, URINARY INCONTINENCE AND VAGINAL VAULT PROLAPSE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BURNING SENSATION AND DISCOMFORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MESH EROSION, PAIN, INFECTION, DYSPAREUNIA AND OTHER INJURIES FOLLOWING THE PROCEDURE, 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
    75799 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3492800

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention