BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3023840 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-03018
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REVISION ON (B)(6) 2001 AND (B)(6) 2001. ON (B)(6) 2004, THE PATIENT UNDERWENT A MESH REMOVAL OF THE ERODED PART. ON (B)(6) 2006 THE PATIENT UNDERWENT ERODED MESH REMOVAL. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2011 BECAUSE OF VAGINAL BLEEDING DUE TO THE MESH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 1999 IN ORDER TO TREAT RECTOCELE AND CYSTOCELE CONCURRENTLY WITH AN ABDOMINOSACROCOLPOPEXY, ENTEROCELE REPAIR, BURCH PROCEDURE, RECTOCELE REPAIR, CYSTOSCOPY, AND SUPRAPUBIC CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO VAULT PROLAPSED AND ENTEROCELE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 1999 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    125547 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA MGE238

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention