BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 4192852 · Received October 22, 2014

    Report

    Report Number
    2210968-2014-14844
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    July 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH VAGINAL HYSTERECTOMY, MCCALL CULDOPLASTY, AND CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF SUBURETHRAL SLING ON (B)(6) 2013 BY DR. (B)(6) DUE TO SLING EXTRUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IN ADDITION, A DEVICE HISTORY REVIEW HAS BEEN INSERTED INTO THE FILE. THIS REVIEW INDICATES THAT THERE WAS NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    (B)(4) RECEIVED AN E-MAIL FROM THE ETHICON RISK MANAGER TEAM STATING THE FOLLOWING: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    670830 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK 3515858

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention