BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 22039283 · Received May 16, 2025

    Report

    Report Number
    2210968-2025-05472
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    February 20, 2025
    Report Date
    May 16, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTM
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2025 AND MESH WAS IMPLANTED. CLINICAL EVENT INFORMATION: MESH SURGERY. THE MESH THAT WAS PUT INTO THE PELVIC FLOOR CREATED EXTREME PAIN AND DISCOMFORT. IT WAS NOT SUITABLE FOR ME. THE ANCHORS ARE STILL IMBEDDED IN THE PUBIC BONE AND IS PAINFUL. THE OUTCOME WAS PARTIAL REMOVAL OF THE MESH BY A REFERRED DOCTOR. IT LEFT ME WITH SOME MESH AND PUDENDAL NERVE DAMAGE, PLUS BLADDER PROBLEMS. I LATER HAD A NATIVE REPAIR THAT WAS SUCCESSFUL. IT FINISHED ANY MARITAL RELATIONS AS I SUFFERED SEVERE PAIN. THE PAIN IS STILL ONGOING, DESPITE SEVERAL TREATMENTS OF BILATERAL RYZOTOMYS NUMEROUS TIMES. I REPORTED TO THE MEDICAL STAFF OF THE EXTREME PAIN AND WAS LARGELY IGNORED. DESPITE THE FACT I WAS IN OBVIOUS PAIN, IT WAS DISMISSED AND ONLY SUPPLIED PAIN KILLERS. I COULD NOT SLEEP BECAUSE OF THE PAIN. I REPORTED TO THE MEDICAL BOARD, BUT IT WAS DISMISSED. THE OPERATING DOCTOR WROTE TO THE MEDICAL BOARD IN RESPECT OF MY COMPLAINT AND SUGGESTED I WAS MENTALLY UNBALANCED AT THE TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142643 GYNECARE MESH UNKNOWN MESH, SURGICAL FTM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention