BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2953835 · Received February 10, 2013

    Report

    Report Number
    2210968-2013-00927
    Event Type
    Injury
    Date Received
    February 10, 2013
    Report Date
    January 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT PELVIC ORGAN PROLAPSE, CERVICAL HYPERTROPHY, ENTEROCELE, AND COMPLICATION OF MESH PLACED.IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2011 BY DR. (B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005 DUE TO INCOMPLETE UTEROVAGINAL PROLAPSE, CYSTOCELE, STRESS URINARY INCONTINENCE, FREQUENCY AND URGENCY. FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL CONCURRENTLY WITH LAPAROSCOPIC SIGMOID COLON RESECTION AND REPAIR OF UMBILICAL HERNIA ON (B)(6) 2010 DUE TO CHRONIC PHLEGMON. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT ROBOTIC-ASSISTED EXPLORATORY LAPAROSCOPY, RIGHT SALPINGO-OOPHORECTOMY, POSTERIOR COLPORRHAPHY, AND CYSTOURETHROSCOPY ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO CHRONIC PELVIC PAIN STATUS POST MULTIPLE ABDOMINAL AND BOWEL SURGERIES, VAGINAL PROLAPSE, RECTOCELE, URINARY URGENCY, AND FREQUENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT PELVIC ORGAN PROLAPSE, CERVICAL HYPERTROPHY, ENTEROCELE, AND COMPLICATION OF MESH PLACED.IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2011 BY DR. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ROBOTIC-ASSISTED EXPLORATORY LAPAROSCOPY, RIGHT SALPINGO-OOPHORECTOMY, POSTERIOR COLPORRHAPHY, AND CYSTOURETHROSCOPY ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6) HOSPITAL DUE TO CHRONIC PELVIC PAIN STATUS POST MULTIPLE ABDOMINAL AND BOWEL SURGERIES, VAGINAL PROLAPSE, RECTOCELE, URINARY URGENCY, AND FREQUENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57870 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UAB904

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention