BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3023737 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-03033
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    May 9, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 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 BY AN ATTORNEY THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING, AND OTHER. IT WAS REPORTED THAT THE PATIENT UNDERWENT RESECTION OF EXPOSED MESH ON (B)(6) 2010 AND (B)(6) 2010 DUE TO MESH EXPOSURE, SPOTTING BLOOD, VAGINAL INFECTIONS, URINARY PROBLEMS, AND BLADDER PROLAPSE. IT WAS REPORTED THAT THE PATIENT ALSO UNDERWENT RESECTION OF SMALL RESIDUAL GRAFT EROSION ON (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126112 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3222451

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention