BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 3191291 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11280
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    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

    ADDITIONAL NARRATIVE: CONCURRENT PROCEDURES INCLUDED ABDOMINAL HYSTERECTOMY, ABDOMINAL SACRAL COLPOPEXY, PARAVAGINAL REPAIR, BURCH CYSTOURETHROPEXY, POSTERIOR REPAIR, SPHINCTEROPLASTY. THE PATIENT UNDERWENT REMOVAL OF EXPOSED MESH FROM THE VAGINAL VAULT BY THE IMPLANTING SURGEON ON (B)(6) 2005. (B)(4) - MESH EXPOSURE.

    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 FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, EROSION, RECURRENCE, BLEEDING AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289826 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL FTL ETHICON INC. UNK SAE613

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention