BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 11761685 · Received May 3, 2021

    Report

    Report Number
    2210968-2021-04127
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    May 4, 2010
    Report Date
    April 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO FDA: (B)(6) 2021. CORRECTED: G1 MANUFACTURING SITE ADDRESS. THIS FOLLOW UP IS BEING SUBMITTED TO REPORT THE MANUFACTURER SITE ADDRESS THAT SHOULD HAVE BEEN CAPTURED ON THE INITIAL FOR MWR-09042021-0000935159.

    Additional Manufacturer Narrative · 1

    (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. EVENTS RELATED TO TVT CAPTURED VIA 2210968-2021-04126. CITATION: INT UROGYNECOL J (2010); 21:1049¿1055. DOI 10.1007/S00192-010-1160-Y.

    Description of Event or Problem · 1

    TITLE: A RANDOMIZED TRIAL COMPARING TENSION-FREE VAGINAL TAPE WITH TENSION-FREE VAGINAL TAPE-OBTURATOR: 36-MONTH RESULTS. THIS IS A RANDOMIZED MULTICENTER STUDY COMPARING TWO MID-URETHRA TAPE PROCEDURES, THE TENSION-FREE VAGINAL TAPE (TVT) WITH THE TENSION-FREE VAGINAL TAPE-OBTURATOR (TVT-O) IN TERMS OF CURE RATE AND COMPLICATION RATE. BETWEEN MARCH 2004 TO NOVEMBER 2005, A TOTAL OF 267 FEMALE PATIENTS UNDERWENT THE ALLOCATED OPERATION: 136 IN THE TVT GROUP AND 131 IN THE TVT-O GROUP. AT THE 36-MONTH FOLLOW-UP, 257 PATIENTS (96%) WERE EVALUATED AND ONLY 10 PATIENTS WERE LOST TO FOLLOW-UP. REPORTED COMPLICATIONS INCLUDED IN THE TVT GROUP WERE OBJECTIVE NON-CURE RATE/FAILURE (N=?); 24-H PAD TEST OF >8 G (N=?); DE NOVO URGENCY (N=12) AND USED ANTICHOLINERGIC TREATMENT AT THE 3-YEAR FOLLOW-UP VISIT IN 3 PATIENTS; URINARY TRACT INFECTIONS (N=8%) THAT REQUIRED ANTIBIOTIC TREATMENT DURING THE FOLLOW-UP TIME AFTER 2 MONTHS; URINARY TRACT INFECTIONS (N=14.2%) THAT REQUIRED ANTIBIOTIC TREATMENT DURING THE FOLLOW-UP TIME AFTER 12 MONTHS; URINARY TRACT INFECTIONS (N=15.4%) THAT REQUIRED ANTIBIOTIC TREATMENT DURING THE FOLLOW-UP TIME AFTER 36 MONTHS; RECURRENT URINARY TRACT INFECTIONS (N=1) WHICH REQUIRED USED OF LONG-TERM PROPHYLACTIC ANTIBIOTICS DURING THE TIME PERIOD BETWEEN THE 1- AND THE 3-YEAR FOLLOW-UP VISIT; PVR VOLUME OF 111 ML (N=1); PVR VOLUME OF 115 ML (N=1); UNKNOWN EVENT (N=2) WHICH REQUIRED REOPERATION WITH A TVT PROCEDURE BECAUSE THEY WERE NOT SATISFIED WITH THE RESULT, ONE OF THESE LOST TO FOLLOW-UP, AND THE OTHER WAS CONTINENT AFTER THE EVALUATION. IN THE TVT-O GROUP WERE OBJECTIVE NON-CURE RATE/FAILURE (N=?); 24-H PAD TEST OF >8 G (N=?); DE NOVO URGENCY (N=7); URINARY TRACT INFECTIONS (N=13%) THAT REQUIRED ANTIBIOTIC TREATMENT DURING THE FOLLOW-UP TIME AFTER 2 MONTHS; URINARY TRACT INFECTIONS (N=16.8%) THAT REQUIRED ANTIBIOTIC TREATMENT DURING THE FOLLOW-UP TIME AFTER 12 MONTHS; URINARY TRACT INFECTIONS (N=17.6%) THAT REQUIRED ANTIBIOTIC TREATMENT DURING THE FOLLOW-UP TIME AFTER 36 MONTHS; RECURRENT URINARY TRACT INFECTIONS (N=5) WHICH REQUIRED USED OF LONG-TERM PROPHYLACTIC ANTIBIOTICS DURING THE TIME PERIOD BETWEEN THE 1- AND THE 3-YEAR FOLLOW-UP VISIT, ONE PATIENT CONTINUED PROPHYLACTIC ANTIBIOTIC TREATMENT AFTER THE 3-YEAR FOLLOW-UP VISIT; PVR VOLUME OF 110 ML WHO REPORTED OCCASIONAL VOIDING PROBLEMS (N=1); PVR VOLUME OF 112 ML WHO HAD EXPERIENCED A TOTAL OF NINE URINARY TRACT INFECTION SINCE THE OPERATION (N=1); PVR VOLUME OF 121 ML WHO DEVELOPED A GRADE 2 PROLAPSE - A RECTOCELE (N=1), BUT HAD NO COMPLAINTS OF VOIDING DIFFICULTIES AND HAD NOT EXPERIENCED URINARY TRACT INFECTIONS; PVR VOLUME OF 302 ML WHO DEVELOPED A GRADE 2 PROLAPSE - A CYSTOCELE (N=1), BUT HAD NO COMPLAINTS OF VOIDING DIFFICULTIES AND HAD NOT EXPERIENCED URINARY TRACT INFECTIONS; TAPE EROSION AT THE 1-YEAR FOLLOW-UP VISIT (N=1) WHICH REQUIRED TAPE RESECTION THAT RESULTED IN RECURRENCE OF INCONTINENCE AND A TVT RE-OPERATION WAS PERFORMED, AND WAS CONTINENT AFTER THE EVALUATION; RETENTION PROBLEM (N=1) WHICH REQUIRED DIVISION OF THE TAPE PERFORMED TWICE, AND THE RETENTION RESOLVED AFTER THE LAST DIVISION OF THE TAPE, BUT THE PATIENT DEVELOPED DE NOVO URGE SYMPTOMS. IN CONCLUSION, THE TVT AND THE TVT-O ARE EQUALLY EFFECTIVE IN THE TREATMENT OF STRESS URINARY INCONTINENCE AFTER 36-MONTH FOLLOW-UP WITH NO DIFFERENCE IN COMPLICATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660271 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention