BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 9833794 · Received March 16, 2020

    Report

    Report Number
    2210968-2020-02105
    Event Type
    Injury
    Date Received
    March 16, 2020
    Report Date
    February 23, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: (B)(6)2020. ADDITIONAL INFORMATION: CONCOMITANT PRODUCTS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (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. DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR DOCTOR/SURGEON IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? IF IN YOUR POSSESSION, MAY WE HAVE COPIES OF YOUR OPERATIVE REPORTS (INITIAL SURGERY WHEN GYNEMESH PS MESH WAS IMPLANTED) AND MEDICAL RECORDS INCLUDING 2013 AND 2019 MESH EROSION? THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE REPORT # MW 5093259.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL HYSTERECTOMY AND LAPAROSCOPIC SACROCOLPOPEXY ON (B)(6) 2009 AND THE MESH WAS IMPLANTED CONCURRENTLY WITH UNKNOWN BRAND OF VAGINAL MID-URETERAL SLING AND MINIARC. FOR YEARS THE PATIENT EXPERIENCED COMPLICATIONS SUCH AS DYSPAREUNIA AND BLADDER ISSUES AND WAS TAKING A DAILY MEDICATION FOR BLADDER CONTROL. THE PATIENT WAS OFFICIALLY DIAGNOSED WITH A MESH EROSION IN 2019. THE PATIENT STATED THAT SHE HAD MESH EROSION IN 2013; HOWEVER, THE PATIENT WAS NOT COUNSELED ON THIS AS WAS TOLD IT WAS A NORMAL PART OF THE HEALING PROCESS. THE CONSTANT PAIN AFTER INTERCOURSE LED THE PATIENT BACK TO THE DOCTOR. SINCE THE SURGERY, THE PATIENT HAS SEEN MANY SPECIALISTS WHO RECOMMENDED A SURGERY TO REPAIR THE DAMAGED AREA WHERE THE MESH EROSION IS LOCATED; ALSO BEEN WARNED OF THE RISKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300784 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 MINIARC SLING| UNKNOWN VAGINAL MID-URETERAL SLING