BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2970318 · Received February 20, 2013

    Report

    Report Number
    2210968-2013-01286
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ETHICON INC
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY, BLADDER WASHINGS, BILATERAL RETROGRADE PYELOGRAMS, BLADDER BIOPSY, BLADDER FULGURATION, HYDRODISTENTION OF THE URINARY BLADDER, AND INTRAVESICAL INSTALLATION OF MEDICATION DUE TO SUI AND INTERSTITIAL CYSTITIS. 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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY, BLADDER WASHING, BILATERAL RETROGRADE PYLOGRAM, BLADDER BIOPSY, AND BLADDER FULGURATION, HYDRODISTENTION OF THE URINARY BLADDER, MESH, AND INTRAVESTICAL INSTILLATION OF MEDICINE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, AND NEUROMUSCULAR PROBLEMS.

    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. THE PATIENT 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
    73247 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON INC NA 3118809

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention