BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 3053398 · Received April 11, 2013

    Report

    Report Number
    2210968-2013-03743
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A CYSTOCELE AND A RECTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). 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). 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). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND ABNORMAL PELVIC PROLAPSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH AND BOSTON SCIENTIFIC OBTRYX WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE 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
    155683 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL OTP ETHICON, INC. NA 3507130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC OBTRYX| BOSTON SCIENTIFIC OBTRYX