BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 18876723 · Received March 11, 2024

    Report

    Report Number
    2210968-2024-02821
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 2, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. AN ATTEMPT HAS BEEN 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 THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED CITATION: UROGYNECOLOGY 2023, DOI: 10.097/SPV.0000000000001284. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: SAFETY AND EFFICACY OF SINGLE INCISION SLING VERSUS MIDURETHRAL SLING IN THE TREATMENT OF STRESS URINARY INCONTINENCE: A RANDOMIZED CONTROLLED TRIAL. THE AIM OF THIS STUDY IS TO EVALUATE EFFICACY AND SAFETY OF THE OPHIRA SIS IN COMPARISON WITH THE INSIDE-OUT TOT SLING DURING A LONG-TERM FOLLOW-UP. FROM 192 ELIGIBLE PATIENTS, A TOTAL OF 168 PATIENTS (87.5%) WERE RANDOMIZED INTO SIS (N = 84) AND TOT GROUPS (N = 84). FINALLY, 66 PATIENTS (78.6%) IN THE SIS GROUP AND 64 PATIENTS (76.2%) IN THE TOT GROUP COMPLETED THE 4-YEAR FOLLOW-UP. FOR THE TOT PROCEDURE, THE INSIDE-OUT GYNECARE TVT OBTURATOR SYSTEM (ETHICON) WAS USED. THE SIS PROCEDURE WAS PERFORMED WITH AN OPHIRA (PROMEDON - COMPETETOR) SURGICAL KIT. PATIENTS IN BOTH TOT SLING AND SIS STUDY GROUPS WERE TREATED WITH STANDARDIZED SURGICAL TECHNIQUES IN ACCORDANCE WITH MANUFACTURER INSTRUCTIONS. REPORTED COMPLICATION(S): URINE RETENTION (N- 3) TAPE EXPOSURE/EXTRUSION (N-1) CONCLUSION: AFTER LONG-TERM FOLLOW-UP, ANTI-INCONTINENCE SIS SURGERY PROVED NONINFERIOR TO THE INSIDE-OUT TOT PROCEDURE IN TERMS OF OBJECTIVE AND SUBJECTIVE CURE RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454462 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention