BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3032607 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03129
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING, STRESS, ANXIETY ABOUT PAIN, WEIGHT LOSS, DIFFICULTY SLEEPING, WEAKNESS AND LACK OF ENERGY. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND EXCISION OF MESH IMPLANT ON (B)(6) 2010 IN ORDER TO RELIEVE PAIN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF NICHOLS SACROSPINOUS SUSPENSION AND CYSTOSCOPY DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, BOWEL PROBLEMS, STRESS, ANXIETY, WEIGHT LOSS , DIFFICULTY SLEEPING, WEAKNESS AND LACK OF ENERGY. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND EXCISION OF MESH IMPLANT ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS 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
    135802 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention