BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 11912430 · Received June 1, 2021

    Report

    Report Number
    2210968-2021-05096
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    January 1, 2015
    Report Date
    May 4, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).   THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED.  THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.  CITATION: FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY. 2015; 21: 263¿268. DOI: 10.1097/SPV.0000000000000161. 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.   WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS (TENSION FREE VAGINAL TAPE, TENSION FREE VAGINAL TAPE - OBTURATOR) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? PATIENT DEMOGRAPHICS. ADVERSE EVENTS ASSOCIATED WITH TENSION FREE VAGINAL TAPE DEVICE REPORTED VIA MW # 2210968-2021-05095.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ULTRASOUND EVALUATION OF MID-URETHRAL SLING POSITION AND CORRELATION TO PHYSICAL EXAMINATION AND PATIENT SYMPTOMS. THE PRIMARY OBJECTIVE OF THIS CROSS-SECTIONAL STUDY WAS TO EVALUATE THE POSITION AND ANGLE VARIATION BETWEEN 3 DIFFERENT MID-URETHRAL SLINGS (MUSS) USING 3-DIMENSIONAL ULTRASOUND (US) TECHNOLOGY. THE SECONDARY OBJECTIVE WAS TO COMPARE DIFFERENCES IN FINDINGS ON PHYSICAL EXAMINATION AND SYMPTOMS OF INCONTINENCE AND SEXUAL DYSFUNCTION BETWEEN SUBJECTS. A TOTAL OF 61 SUBJECTS (MEDIAN AGE = 53 YEARS; AGE RANGE = 34-81 YEARS; MEDIAN BMI = 27.8 KG/M2) WHO UNDERWENT MUS PLACEMENT WITHOUT CONCOMITANT ANTERIOR OR APICAL COMPARTMENT PROLAPSE SURGERY (21 RETROPUBIC [RP], 19 OUT-TO-IN TRANS-OBTURATOR [TOT], 21 IN-TO-OUT TRANS-OBTURATOR [TVT-O]). ALL RP SLINGS IN THIS STUDY WERE TVT TYPE (GYNECARE TVT RETROPUBIC SYSTEM, ETHICON), OUT-TO-IN TO SLINGS (TOT) USED IN THIS STUDY WERE MONARC (AMERICAN MEDICAL SYSTEMS, MINNETONKA, MN), AND IN-TO-OUT TO SLINGS WERE TVT-O (ETHICON INC). REPORTED COMPLICATIONS INCLUDED PALPABLE SLING (N=8); MESH EXPOSURE (N=3); URETHRAL HYPERMOBILITY (N=8); DISCOMFORT DURING INTERCOURSE WHICH INCLUDES NARROWING OF THE VAGINA, GROIN OR PELVIC PAIN, PAINFUL INTERCOURSE EITHER DUE TO THE NARROWING OR AS A RESULT OF FEELING THE SLING (N=10). IN CONCLUSION, ON 3-DIMENSIONAL US, RP SLING ANGLE WAS FOUND TO BE SIGNIFICANTLY MORE ACUTE THAN THE ANGLES OF THE TOT AND TVT-O SLINGS, AND THERE WAS NO DIFFERENCE BETWEEN THE 2 TRANS-OBTURATOR SLINGS. THE TOT SLING WAS MORE OFTEN PALPABLE ON EXAMINATION, BUT THIS FINDING DID NOT CORRELATE WITH INCREASED PAIN ON PALPATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807720 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention