BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT DISPOSABLE KIT

    MDR report key: 9943970 · Received April 9, 2020

    Report

    Report Number
    2210968-2020-02780
    Event Type
    Injury
    Date Received
    April 9, 2020
    Report Date
    April 7, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 07/09/2021. ADDITIONAL INFORMATION: D1, D3, D4, E1, G1 DATE SENT TO THE FDA: 07/09/2021. CORRECTED INFORMATION: D6A. CORRECTED B5 NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 7/12/2021.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN INCONTINENCE CORRECTION GYNECOLOGICAL SURGICAL PROCEDURE IN 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407106 TVT DISPOSABLE KIT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1067143

    Patients

    Seq Age Sex Outcome Treatment
    1