BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT ABREVO CONTINENCE SYSTEM

    MDR report key: 5188233 · Received October 29, 2015

    Report

    Report Number
    2210968-2015-16577
    Event Type
    Injury
    Date Received
    October 29, 2015
    Report Date
    November 22, 2017
    Manufacturer
    ETHICON SARL
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    "PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHERTHIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN"WE ARE ATTEMPTING TO GET THE UNIT BACK FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCONTINENCE, URGENCY AND PELVIC PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNDISCLOSED DATE AND AN UNK MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718794 GYNECARE TVT ABREVO CONTINENCE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON SARL UNK 3520797

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention