BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT W/PRLNE BLUE MESH 1 EACH

    MDR report key: 17372289 · Received July 21, 2023

    Report

    Report Number
    2210968-2023-05287
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    November 1, 2005
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000322
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2005 AND MES WAS IMPLANTED FOR STRESS URINARY INCONTINENCE ASSOCIATED WITH URETROCELE. IN (B)(6) 2005, THE PATIENT EXPERIENCED FIRST DISABLING SYMPTOMS 1 MONTH AFTER INSTALLATION. THE PATIENT EXPERIENCED SEVERE PELVIC PAIN GRADUALLY (6 MONTHS AFTER INSTALLATION), LOWER COLUMN AND LEG PAIN SPREAD, RIB CAGE. GRADUALLY IMPRESSION "LEGS THAT LET GO". THE PATIENT FURTHER REPORTED INCOMPREHENSION AND "ASTONISHMENT" OF RHEUMATOLOGIST AT THE SYMPTOMS. OSTEOPATH-RHUMATO DECIDED TO STOP HIS INTERVENTIONS IN THE FACE OF THE INCREASE IN SYMPTOMS AND DIFFICULTIES INCREASING WALKING AND STANDING. THE PAIN IS DAY AND NIGHT. THERE HAS BEEN IMPROVEMENT IN THE PELVIS AND SPINE BUT PERMANENT PAIN (SCALE 3) AND INCREASE ON EXERTION (8/9 SCALE). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921420 GYNECARE TVT W/PRLNE BLUE MESH 1 EACH MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810041B 10705031000322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other