BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3111127 · Received May 14, 2013

    Report

    Report Number
    2210968-2013-05480
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT HAD REMEEX IMPLANTED ON 01/07/2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009. (B)(4).

    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 THE PATIENT CONCURRENTLY UNDERWENT LYSIS OF ADHESIONS, ABDOMINAL SACRO-COLPOPEXY WITH ANTERIOR EXTENSION, ABDOMINAL PARAVAGINAL DEFECT REPAIR, ABDOMINAL ENTEROCELE REPAIR, PERINEOPLASTY, AND CYSTOSCOPY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, FREQUENCY AND INCOMPLETE BLADDER EMPTYING. IT WAS REPORTED THAT THE PATIENT UNDERWENT OVERLAPPING SPHINCTEROPLASTY, RECTOCELE REPAIR AND REPAIR OF PERINEOCELE ON (B)(6) 2014 BY DR. (B)(6) MD DUE TO RECTOCELE, PERINEOCELE, CONSTIPATION, OUTLET OBSTRUCTION, DEFECATORY DYSFUNCTION AND FECAL INCONTINENCE/SOILING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH AND ELEVATE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT LYSIS OF ADHESIONS, ABDOMINAL SACRO-COLPOPEXY WITH ANTERIOR EXTENSION, ABDOMINAL PARAVAGINAL DEFECT REPAIR, ABDOMINAL ENTEROCELE REPAIR, PERINEOPLASTY, AND CYSTOSCOPY.

    Description of Event or Problem · 1

    DETAILS: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY, FREQUENCY AND INCOMPLETE BLADDER EMPTYING. IT WAS REPORTED THAT THE PATIENT UNDERWENT OVERLAPPING SPHINCTEROPLASTY, RECTOCELE REPAIR AND REPAIR OF PERINEOCELE ON (B)(6) 2014 BY DR. (B)(6) MD DUE TO RECTOCELE, PERINEOCELE, CONSTIPATION, OUTLET OBSTRUCTION, DEFECATORY DYSFUNCTION AND FECAL INCONTINENCE/SOILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213541 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA AHR341

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention