BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18816252 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02183
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    August 24, 2022
    Report Date
    March 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. 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. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.31083/J.CEOG4909193.

    Description of Event or Problem · 0

    TITLE: THE EFFECTS OF SUBURETHRAL TENSION ADJUSTABLE SLING (REMEEX SYSTEM) FOR FEMALE URINARY INCONTINENCE BETWEEN PURE INTRINSIC SPHINCTER DEFICIENCY AND INTRINSIC SPHINCTER DEFICIENCY WITH OVERACTIVE BLADDER: INITIAL EXPERIENCE WITH PROPENSITY SCORE MATCHING. THE OBJECTIVE OF THIS STUDY IS TO COMPARE THE THERAPEUTIC EFFICACY AFTER SUBURETHRAL ADJUSTABLE SLING (REMEEX SYSTEM) FOR FEMALE STRESS URINARY INCONTINENCE (SUI) BETWEEN PURE INTRINSIC SPHINCTER DEFICIENCY (ISD) AND ISD WITH OVERACTIVE BLADDER (OAB) GROUP. BETWEEN JANUARY 2012 TO JANUARY 2015, A TOTAL OF 158 PATIENTS UNDERWENT REMEEX SYSTEM IMPLANTATION FOR SUI DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD). FROM THIS GROUP, 131 PATIENTS WERE INCLUDED IN THIS RETROSPECTIVE ANALYSIS. WE RETROSPECTIVELY STUDIED BOTH PATIENTS WHO UNDERWENT REMEEX SYSTEM DUE TO PURE ISD (GROUP I) AND THOSE WHO UNDERWENT REMEEX SYSTEM DUE TO ISD WITH OAB (GROUP II). GROUP I INCLUDED 43 PATIENTS AND GROUP II INCLUDED 43 PATIENTS OF MEAN AGES 56.8 ± 7.5 AND 57.4 ± 6.6 YEARS, RESPECTIVELY. THREE PATIENTS IN GROUP I AND 1 PATIENT IN GROUP II DEVELOPED SKIN WOUND INFECTION, BUT THEIR VARITENSORS WERE NOT REMOVED. IN ALL FOUR OF THESE PATIENTS, THE INFECTIONS RESOLVED AFTER 1 WEEK OF ORAL ANTIBIOTICS AND WOUND DRESSING. IN THE REGION SUPERIOR TO THE PUBIC SYMPHYSIS, A 3- TO 4-CM INCISION WAS MADE IN THE TRANSVERSE DIRECTION AND THE FASCIA OF THE RECTUS MUSCLES WAS EXPOSED. TRACTION NEEDLES (THREADS) WERE INSERTED TO PASS TWO NON-ABSORBABLE PROLENE SUTURES THROUGH THE RETROPUBIC SPACE FROM THE ANTERIOR VAGINAL WALL THROUGH THE RECTUS FASCIA OF THE ABDOMINAL INCISION. THE ANTERIOR VAGINAL WALL AND THE INFERIOR ABDOMINAL AREA WERE SUTURED USING GENERAL METHODS. REPORTED COMPLICATION: GROUP I: PURE ISD. SKIN WOUND INFECTION (N=3). GROUP II: ISD WITH OAB. SKIN WOUND INFECTION (N=1). IN CONCLUSION, THE REMEEX SYSTEM SHOWED A GREATER PATIENT SATISFACTION AND A HIGHER CURE RATE IN PURE ISD THAN ISD WITH OAB IN FEMALE PATIENTS WITH URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296893 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention