BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 9399504 · Received December 2, 2019

    Report

    Report Number
    2210968-2019-90407
    Event Type
    Injury
    Date Received
    December 2, 2019
    Report Date
    November 12, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE PATIENT DEMOGRAPHIC INFO: AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? DATE, INDICATION AND NAME OF INITIAL SURGICAL PROCEDURE WHEN THE MESH WAS IMPLANTED? OTHER RELEVANT PATIENT COMORBIDITIES? PRODUCT CODE AND LOT NUMBER? PLEASE CLARIFY WHAT IS LSE AND RIF? ONSET-TIME OF BLADDER PAIN, UTIS, RIF, LSE AND CHRONIC INFLAMMATION FROM THE INITIAL IMPLANTATION SURGERY? SPECIFY A LOCATION OF INFLAMMATION, TREATMENT AND RESULTS? WHAT IS AN INDICATION FOR MESH REMOVAL? IF MESH WAS REMOVED, PLEASE PROVIDE A DATE AND SURGICAL FINDINGS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THESE EVENTS, (BLADDER PAIN, RIF, RECURRENT UTIS, CONCURRENT LSE AND CHRONIC INFLAMMATION)? WHAT IS THE PATIENT'S CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON UNKNOWN DATE AND THE MESH WAS IMPLANTED. THE PATIENT IS EXPERIENCING BLADDER AND RIGHT ILIAC FOSSA PAIN, RECURRENT URIS AND IS ON ORAMORPH, MST, PREGABALIN AND NORTRYPTILINE. IT WAS ALSO REPORTED THAT THE PATIENT HAS CONCURRENT LSE, NOT RESPONDED TO TOPICAL VAGINAL ESTROGENS OR PROPHYLAXIS AGAINST UTIS. CYSTOSCOPY WAS PERFORMED AND THERE IS NO TAPE EROSION, BUT CHRONIC INFLAMMATION. THE PATIENT DEBILITATED BY PAIN, ABOUT TO LOSE JOB THROUGH REPEATED EPISODES OF SICKNESS. MESH REMOVAL IS IN DISCUSSION STAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193649 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention