BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2923806 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00461
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF ANTERIOR & POSTERIOR COLPORRHAPHY, VAGINAL PARAVAGINAL REPAIR, VAGINAL ENTEROCELE REPAIR, BILATERAL EXTRAPERITONEAL SACROSPINOUS COLOPEXY; LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY, LAPAROSCOPIC LYSIS OF ADHESIONS AND CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT PELVIC ORGAN PROLAPSE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY AND BOWEL PROBLEMS, BLEEDING AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANT ON (B)(6) 2012 DUE TO MESH EROSION. (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 USED. 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
    29443 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3077463

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention