BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10722098 · Received October 22, 2020

    Report

    Report Number
    2210968-2020-08240
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    January 1, 2019
    Report Date
    October 5, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE) 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 (PROLENE SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS: CITATION: DOI: INTERNATIONAL UROGYNECOLOGY JOURNAL (2019) 30:393¿399 HTTPS://DOI.ORG/10.1007/S00192-018-3621-7.

    Description of Event or Problem · 1

    TITLE: OUTCOME OF ROLLED FORTIFIED VAGINAL FLAP OPERATION ON FEMALE PATIENTS WITH INTRINSIC SPHINCTERIC DEFICIENCY: 2-YEAR FOLLOW-UP. THE AIM OF THIS PROSPECTIVE STUDY IS TO EVALUATE THE USE OF THE ROLLED FORTIFIED VAGINAL FLAP (RFVF) OPERATION IN THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTERIC DEFICIENCY (ISD), ADDRESSING ITS TECHNICAL FEASIBILITY, COMPLICATIONS, OUTCOME, AND ITS IMPACT ON THE QUALITY OF LIFE OF THE PATIENTS. A TOTAL OF 20 CONSECUTIVE FEMALE PATIENTS WITH MEAN AGE OF 53 ± 8 YEARS UNDERWENT ROLLED FORTIFIED VAGINAL FLAP (RFVF) OPERATION FOR THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTERIC DEFICIENCY (ISD). DURING THE PROCEDURE, A PLACEMENT OF TWO DIAGONAL ROWS OF ZERO PROLENE (ETHICON) SUTURES WITHIN THE FLAP WAS USED FOR REINFORCEMENT. THEN THE FLAP WAS ROLLED UPON ITSELF, COVERING THE PROLENE (ETHICON) THREADS AND FORMING A STRONG CYLINDRICAL STRUCTURE TO SUPPORT THE URETHRA FROM BEHIND. THE ROLLED FLAP IS NOW SUSPENDED BY TWO THREADS FROM EITHER SIDE THAT ARE PASSED INTO THE SUPRAPUBIC REGION USING STAMEY NEEDLES FROM ABOVE THROUGH TWO ABDOMINAL INCISIONS 3 CM FROM THE MIDLINE ON EACH SIDE. THE TWO SUTURES ARE TIED ABOVE THE RECTUS SHEATH WITHOUT ANY TENSION AND ARE TIED TO EACH OTHER. POSTOPERATIVE COMPLICATIONS INCLUDED TRANSIENT URINARY RETENTION (N=1) WHICH WAS RELIEVED BY A TEMPORARY URETHRAL CATHETER INSERTED FOR 5 DAYS; AND MILD URINARY OBSTRUCTIVE SYMPTOMS (N=4) AT THE 6-MONTH FOLLOW-UP WHICH DECREASED TO TWO CASES AFTER 12 MONTHS OF FOLLOW-UP. THE RFVF OPERATION IS A SAFE AND CHEAP PROCEDURE FOR THE TREATMENT OF FEMALE ISD. IT CARRIES A HIGH SUCCESS RATE AND LEADS TO IMPROVEMENT OF THE PATIENTS¿ QUALITY OF LIFE AFTER A 2-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187595 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention