BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2760527 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05633
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTM
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING DEPRESSION, ANXIETY GRIEF AND SEVERE ABDOMINAL BLOATING. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DUE TO PAIN, EROSION, INFECTIONS, NEUROMUSCULAR PROBLEMS AND BLEEDING, PATIENT UNDERWENT TRIMMING OF MESH ON (B)(6) 2002, PARTIAL REMOVAL OF MESH ON (B)(6) 2002, PARTIAL REMOVAL ON (B)(6) 2010 AND MESH EXPLANTATION ON (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED HEMATURIA, AND URGENCY. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2015 BY DR. (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND A SLING 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTM ETHICON INC NA 925513

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention