BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 20353121 · Received October 2, 2024

    Report

    Report Number
    2210968-2024-10487
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    April 28, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 2022;28:444¿451. HTTP://DOI.ORG/10.1097/SPV.0000000000001192.

    Description of Event or Problem · 0

    TITLE: RISK FACTORS FOR BLADDER PERFORATION AT THE TIME OF RETROPUBIC MIDURETHRAL SLING PLACEMENT. THE AIMS OF THE STUDY WERE TO DESCRIBE THE INCIDENCE OF AND FACTORS ASSOCIATED WITH BLADDER PERFORATION DURING RETROPUBIC MIDURETHRAL SLING PLACEMENT AND TO EXPLORE WHETHER RETROPUBIC HYDRODISSECTION DECREASES THE LIKELIHOOD OF PERFORATION. BETWEEN JANUARY 2007 AND JANUARY 2017, 1,187 WOMEN WHO UNDERWENT RETROPUBIC MIDURETHRAL SLING PLACEMENT WERE INCLUDED IN THE STUDY. THE PATIENTS¿ MEAN AGE WAS 56 ± 13 YEARS AND THE MEAN BMI WAS 30 ± 6 KG/M2. INDICATIONS FOR RETROPUBIC MIDURETHRAL SLING PROCEDURES INCLUDED STRESS, MIXED, OR OCCULT STRESS URINARY INCONTINENCE DOCUMENTED ON A PHYSICAL EXAMINATION AND/OR ON PREOPERATIVE URODYNAMIC TESTING. THE FOLLOWING RETROPUBIC SLINGS WERE USED DURING THE STUDY PERIOD: GYNECARE TVT (ETHICON), GYNECARE TVT EXACT (ETHICON), AND COMPETITOR SLINGS RETROARC, LYNX, AND SPARC. REPORTED COMPLICATIONS INCLUDED BLADDER PERFORATION (N=70), VAGINAL PERFORATION (N=?), HEMATOMA (N=?) URINARY TRACT INFECTION (N=?), AND VOIDING DYSFUNCTIONS DEFINED AS HESITANCY, SLOW STREAM, INTERMITTENCY, STRAINING TO VOID, SPRAYING OF URINARY STREAM, FEELING OF INCOMPLETE BLADDER EMPTYING, NEED TO IMMEDIATELY REVOID POSTMICTURITION LEAKAGE, AND/OR POSITION-DEPENDENT MICTURITION (N=?). IN CONCLUSION, THE INCIDENCE OF BLADDER PERFORATION WAS 8%. THE RISK OF THIS COMPLICATION IS HIGHER IN PATIENTS WITH A BMI LESS THAN 30 AND/OR ENDOMETRIOSIS. RETROPUBIC HYDRODISSECTION MAY NOT DECREASE THE LIKELIHOOD OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948320 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other