BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3073218 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04330
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    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). 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). 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). 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). IT WAS REPORTED THAT PATIENT UNDERWENT MESH PARTIAL REMOVAL ON (B)(6) 2009 AND COMPLETELY REMOVED IN 2010.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A CYSTOCELE, A RECTOCELE, A STAGE 3 ANTERIOR DEFECT, URINARY INCONTINENCE, AND ANTERIOR PROLAPSE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF AN ABDOMINAL SACRAL COLPOPEXY, CYSTOSCOPY, AND EXAMINATION UNDER ANESTHESIA DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, AND DYSPAREUNIA. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXPOSED PORTIONS OF THE MESH WHICH WERE EXCISED ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL IN (B)(6) 2009. THE PATIENT UNDERWENT MESH REMOVAL IN 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT IS REPORTED THAT 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
    174992 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA TBP093

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention