BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 20630464 · Received November 7, 2024

    Report

    Report Number
    2210968-2024-11610
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    February 5, 2023
    Report Date
    November 7, 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
    EG
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: ACTAS UROLÓGICAS ESPAÑOLAS 47 (2023) 279-287. HTTPS://DOI.ORG/10.1016/J.ACUROE.2023.02.004.

    Description of Event or Problem · 0

    TITLE: ABDOMINAL SACROHYSTEROPEXY USING PROLINE MESH VERSUS MERSILENE TAPE IN APICAL PROLAPSE: A RANDOMIZED CLINICAL TRIAL. THE AIM OF THIS RCT STUDY WAS TO COMPARE BETWEEN USING POLYPROLINE MESH AND MERSILENE TAPE IN ABDOMINAL SACROHYSTEROPEXY REPAIRING APICAL PROLAPSE STAGE II OR MORE. BETWEEN NOVEMBER 2019 TO DECEMBER 2021, WOMEN PLANNED SACROHYSTEROPEXY FOR UTERINE PROLAPSE = STAGE 2 ASSIGNED TO TWO GROUPS: MESH GROUP (N = 38), UNDERWENT SACROHYSTEROPEXY WITH POLYPROLINE MESH (UNKNOWN MANUFACTURER), AND TAPE GROUP (N = 38), UNDERWENT SACROHYSTEROPEXY USING MERSILENE TAPE. IN MESH GROUP, THE MESH WAS FIXED TO THE BACK OF CERVIX AT THE LEVEL OF THE INTERNAL OS AT THE LEVEL OF UTEROSACRAL LIGAMENT THEN THE OTHER END TO THE LONGITUDINAL VERTEBRAL LIGAMENT FIXED BY NON-ABSORBABLE PROLINE SUTURES. IN THE TAPE GROUP, MERSILENE TAPE WITH DOUBLE ARMOR NEEDLE WAS USED. IN BOTH PROCEDURE CERVIX LIFTED TO ITS ANATOMICAL POSITION. EXCESS TAPE AND NEEDLES WERE CUT AND REMOVED. MESH OR TAPE WERE COMPLETELY COVERED BY PERITONEUM BY STITCHING THE INCISED PERITONEUM USING VICRYL 2/0 CONTINUOUS SUTURES. REPORTED COMPLICATIONS INCLUDE WOUND SEPSIS, PYREXIA, PAIN REQUIRING MORE POSTOP ANALGESICS, RECURRENCE, DENOVO STAGE II CYSTOCELE, DENOVO SUI, DENOVO UI, AND UNKNOWN EVENT REQUIRING SURGERY. IN CONCLUSION, USING MERSILENE TAPE IN SACROHYSTEROPEXY IS A SAFE ALTERNATIVE TO POLYPROLINE MESH WITH COMPARABLE EFFICACY WITH LESS COMPLICATIONS. TAPE IS EASIER AS IT NEEDS LESS DISSECTION AREA FOR SACRAL FIXATION SO LESS INJURY INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47765 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention