BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20462127 · Received October 16, 2024

    Report

    Report Number
    2210968-2024-10779
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    March 10, 2023
    Report Date
    October 16, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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: J.CLIN. MED. 2023, 12, 2176. HTTPS://DOI.ORG/10.3390/JCM12062176.

    Description of Event or Problem · 0

    TITLE: SACROSPINOUS HYSTEROPEXY VERSUS PROLAPSE HYSTERECTOMY WITH APICAL FIXATION: A RETROSPECTIVE COMPARISON OVER AN 18 YEAR PERIOD. THE AIM OF THIS STUDY WAS TO EVALUATE PERI- AND POSTOPERATIVE OUTCOME PARAMETERS OF UTERINE-PRESERVING SACROSPINOUS HYSTEROPEXY AS AN ALTERNATIVE TREATMENT OPTION TO VAGINAL PROLAPSE HYSTERECTOMY WITH APICAL FIXATION. FROM 2003 TO 2021, 192 PATIENTS WHO UNDERWENT EITHER PRIMARY VAGINAL SACROSPINOUS HYSTEROPEXY (STUDY GROUP) OR PRIMARY PROLAPSE HYSTERECTOMY WITH APICAL FIXATION BY UTEROSACRAL LIGAMENT SUSPENSION (USLS) (CONTROL GROUP) FOR SYMPTOMATIC PELVIC ORGAN PROLAPSE WERE INCLUDED IN THE STUDY. THE PATIENTS¿ MEAN AGE WAS 58.91 YEARS (RANGE, 50.83¿66.76 YEARS). THE MEAN BMI WAS 26.22 KG/M2 (RANGE, 23.33¿29.86 KG/M2). THERE WERE 96 PATIENTS IN EACH OF THE SSH AND HYSTERECTOMY GROUPS. DURING THE SACROSPINOUS HYSTEROPEXY PROCEDURE, THE POSTERIOR SIDE OF THE CERVIX IS JOINED TO THE RIGHT SACROSPINOUS LIGAMENT WITH 2 LATE-ABSORBABLE SUTURES (PDS SUTURES¿0, ETHICON) AT LEAST 2 CM MEDIAL TO THE ISCHIAL SPINE AND THE COLPOTOMY WAS CLOSED VIA ABSORBABLE SUTURES (2/0 VICRYL, ETHICON). DURING THE VAGINAL HYSTERECTOMY PROCEDURE, AFTER REMOVAL OF THE UTERUS, A UTEROSACRAL LIGAMENT SUSPENSION (USLS = ATTACHMENT OF THE UTEROSACRAL LIGAMENTS TO THE VAGINAL VAULT WITH 2 DELAYED-ABSORBABLE SUTURES IN PDS 2.0, ETHICON) WAS PERFORMED TO SUSPEND THE VAULT. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N=6), POSTOPERATIVE PAIN (N=6), VESICOVAGINAL FISTULA (N=1), WOUND INFECTION (N=?), APEX INFECTION (N=1), URINARY TRACT INFECTION (N=10), POSTOPERATIVE RESIDUAL URINE (N=17) AND POSTOPERATIVE BOWEL ISSUE (N=6). IN CONCLUSION, OUR RESULTS CONFIRM THAT A UTERUS-PRESERVING TECHNIQUE HAS MANY BENEFITS AND, THUS, SHOULD BE CONSIDERED AS AN ADDITIONAL INTERMEDIATE STEP IN A LONG-TERM TREATMENT PLAN OF PELVIC ORGAN PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353508 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention