BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR W LASR

    MDR report key: 14957784 · Received July 8, 2022

    Report

    Report Number
    2210968-2022-05275
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    April 1, 2015
    Report Date
    July 8, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062306
    PMA / PMN Number
    K033568
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR URINARY LEAKAGE ON (B)(6) 2009 AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING ACUTE PAIN IN THE RIGHT OBTURATOR MUSCLE WHILE SITTING ON A HARD FLOOR AND 4 WEEKS LATER, HYPERALGIC SCIATICA OCCURRED WHILE RAISING ARMS. THE PATIENT REPORTED BEING BEDRIDDEN 15 DAYS WITHOUT BEING ABLE TO WALK OR SIT AND FEELING OF ELECTRIC SHOCKS THROUGHOUT THE LEG ALONG WITH PHLEBITIS ON THE SAME SIDE. THE PATIENT FURTHER REPORTED THAT THE PAIN WHICH OCCURRED IN (B)(6) 2015 WAS DOWN IN THE GROIN, ON THE INSIDE OF THE THIGH ALMOST TO THE KNEE AND WAS UNBEARABLE FOR 3 MONTHS, FORBIDDING HER TO SIT. THE PATIENT UNDERWENT MEDICAL EXPLORATIONS (RADIO,ECHO) WHICH SHOWED NOTHING AND UNSPECIFIED TREATMENTS WERE INEFFECTIVE. AN OSTEO WAS ABLE TO LOCATE THE PLACE OF THE PAIN AND PROVIDE LITTLE RELIEF. THE PATIENT EXPLAINED THAT THE PAIN BECAME CHRONIC AND COULD NO LONGER RIDE A BIKE OR SIT LONG IN SOME SEATS. THE PATIENT REPORTED THE REASON FOR PAIN WAS DISCOVERED DURING A PETSCAN LAST NOVEMBER (DIAGNOSIS OF LYMPHOMA). THE HEMATOLOGIST SENT THE PATIENT TO CONSULT A GYNECOLOGIST, THEN A UROLOGIST WHO OPINED THAT THE INFLAMMATION WAS DUE TO THE STRIP PLACED IN 2009. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985278 GYNECARE TVT OBTURATOR W LASR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081L 3352382 10705031062306

    Patients

    Seq Age Sex Outcome Treatment
    1 Female