BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7479444 · Received May 2, 2018

    Report

    Report Number
    2210968-2018-72517
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    April 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 ETHICON PRODUCTS 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 USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J. 2013; 24: 1723 1731. DOI: 10.1007/S00192-013-2098-7. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: COMPARISON OF TWO TROCAR-GUIDED TRANS-VAGINAL MESH SYSTEMS FOR REPAIR OF PELVIC ORGAN PROLAPSE: A RETROSPECTIVE COHORT STUDY¿ AUTHORS: E. J. M. LENSEN, M. I. J. WITHAGEN, K. B. KLUIVERS, A. L. MILANI, M. E. VIERHOUT CITATION: INT UROGYNECOL J. 2013; 24: 1723 1731. DOI: 10.1007/S00192-013-2098-7 . THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE FAILURE AND COMPLICATION RATES IN PATIENTS WHO UNDERWENT A TROCAR-GUIDED VAGINAL MESH REPAIR WITH EITHER A NON-ABSORBABLE OR A PARTIALLY ABSORBABLE MESH. A TOTAL OF 569 WOMEN, OF WHICH 347 PATIENTS WERE RANDOMIZED UNDER A TROCAR-GUIDED TENSION FREE VAGINAL NON-ABSORBABLE MESH (PROLIFT) AND 222 PATIENTS UNDERWENT WITH PARTIALLY ABSORBABLE MESH (PROLIFT+M) WERE INCLUDED IN THE STUDY. IN THE NON-ABSORBABLE MESH GROUP, REPORTED COMPLICATIONS INCLUDED BLADDER PERFORATION (N-7), HEMATOMA (N-3), MESH EXPOSURE (N-44), URGENCY URINARY INCONTINENCE (N-106), AND STRESS URINARY INCONTINENCE (N-124). IN THE PARTIALLY ABSORBABLE MESH GROUP, REPORTED COMPLICATIONS INCLUDED BLADDER PERFORATION (N-3), HEMATOMA (N-2), POST-OPERATIVE HEMORRHAGE (N-2) WHICH REQUIRED REPEAT SURGERY, MESH EXPOSURE (N-12), URGENCY URINARY INCONTINENCE (N-46), AND STRESS URINARY INCONTINENCE (N-51). IT WAS CONCLUDED THAT NON-ABSORBABLE AND PARTIALLY ABSORBABLE MESH DEMONSTRATED SIMILAR OUTCOME RATES. THE RISK OF RE-OPERATION WAS LOWER FOR PARTIALLY ABSORBABLE MESH. THE MESH EXPOSURE RATE WAS SIGNIFICANTLY LOWER FOR THE PARTIALLY ABSORBABLE MESH GROUP COMPARED WITH THE NON-ABSORBABLE MESH GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323547 PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention