BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 12457972 · Received September 12, 2021

    Report

    Report Number
    2210968-2021-08345
    Event Type
    Injury
    Date Received
    September 12, 2021
    Date of Event
    January 1, 2020
    Report Date
    August 16, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY (2020); 255: 34¿39. DOI: HTTPS://DOI.ORG/10.1016/J.EJOGRB.2020.09.041. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS (PDS II POLYDIOXANONE SUTURE, TENSION FREE VAGINAL TAPE - OBTURATOR) 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 INVOLVED? PATIENT DEMOGRAPHICS? ADVERSE EVENTS RELATED TO PATIENTS WITH TENSION FREE VAGINAL TAPE - OBTURATOR DEVICE REPORTED VIA MW # 2210968-2021-08346.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PREDICTORS OF VOIDING DYSFUNCTION FOLLOWING UPHOLDTM MESH REPAIR FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE. THE AIM OF THIS RETROSPECTIVE STUDY IS TO IDENTIFY FACTORS ASSOCIATED WITH VOIDING DYSFUNCTION AFTER UPHOLDTM TRANSVAGINAL MESH (TVM) REPAIR IN WOMEN WITH PELVIC ORGAN PROLAPSE (POP). BETWEEN SEPTEMBER 2015 TO DECEMBER 2016, A TOTAL OF 110 FEMALE PATIENTS (MEAN AGE OF 66.7±8.0 YEARS; MEAN BMI OF 25.0±4.6) WITH SYMPTOMATIC PELVIC ORGAN PROLAPSE (POP), ANTERIOR VAGINAL WALL PROLAPSE AND/OR APICAL PROLAPSE (STAGE II TO IV) UNDERWENT UPHOLDTM TVM PROCEDURES. THE VAGINAL MESH WAS FIXED OVER BLADDER NECK AND CERVICAL AREA WITH SIMPLE SUTURE WITH PDS 2-0 (ETHICON). 16 PATIENTS UNDERWENT CONCOMITANT MID-URETHRAL SLING SURGERIES WITH TRANSOBTURATOR SLINGS (GYNECARE TVT-OBTURATOR SYSTEM, ETHICON) AND 6 PATIENTS UNDERWENT SINGLE-INCISION SLING DUE TO CURRENT OR OCCULT STRESS URINARY INCONTINENCE. THE FOLLOW-UP DURATION WAS 24-36 MONTHS. REPORTED COMPLICATIONS INCLUDED MESH EROSION (N=2); VOIDING DYSFUNCTIONS (N=12) WHICH RESOLVED 4¿6 WEEKS POST-OPERATION IN MOST OF THE PATIENTS THROUGH THE COMBINATION OF MEDICAL THERAPY AND CLEAN INTERMITTENT CATHETERIZATION (CIC) TREATMENT; GLUTEAL PAIN (N=?). IN CONCLUSION, WE FOUND THAT HAVING POPDI-6 SCORE OVER 13, AGE OVER 71 YEARS, AND A PREOPERATIVE CONCOMITANT URINARY HESITANCY WITH INCOMPLETE EMPTYING WERE THREE SIGNIFICANT PREDICTORS OF VOIDING DYSFUNCTION AFTER UPHOLDTM MESH REPAIR. WOMEN NEED TO BE COUNSELED REGARDING THE RISK OF POSTOPERATIVE VOIDING DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355304 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1