BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7481579 · Received May 2, 2018

    Report

    Report Number
    2210968-2018-72558
    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 Location
    FR
    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: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 175 (2014) 194¿198; DOI: HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2013.12.031. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: RATE OF RE-INTERVENTIONS AFTER TRANSVAGINAL PELVIC ORGAN PROLAPSE REPAIR USING PARTIALLY ABSORBABLE MESH: 20 MONTHS MEDIAN FOLLOW-UP OUTCOMES¿. AUTHOR(S): JULIE QUEMENER, NICOLAS JOUTEL, JEAN-PHILIPPE LUCOT, GE´ RALDINE GIRAUDET, PIERRE. COLLINET, CHRYSTE` LE RUBOD, MICHEL COSSON. CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 175 (2014) 194¿198; DOI: HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2013.12.031. THE GOAL OF THIS RETROSPECTIVE SINGLE CENTER STUDY WAS TO REPORT THE EXPERIENCE OF USING PARTIALLY ABSORBABLE MESH FOR VAGINAL PROLAPSE REPAIR AND TO ASSESS THE RATES OF REINTERVENTION OBSERVED, WITH A MEDIAN FOLLOW-UP DURATION OF 20 MONTH. BETWEEN JAN2009 AND JAN2011, 250 FEMALE PATIENTS (MEDIAN AGE SD OF 66±8.5 YEARS) WITH SYMPTOMATIC PELVIC ORGAN PROLAPSE STAGE 2 OR MORE WERE TREATED BY TRANSVAGINAL PARTIALLY ABSORBABLE MESH (PROLIFT + M). IN THIS SERIES, MESH RELATED COMPLICATION INCLUDED 5 PATIENTS WHO HAD MESH EXPOSURE WHICH WERE TREATED BY PARTIAL MESH EXCISION. THE AUTHORS STATED THAT COMPLICATION RELATED TO THE MESH WERE LIMITED TO MESH EXPOSURE. THE STUDY DID NOT SHOW THAT PARTIALLY ABSORBABLE PROLIFT + M MESH SIGNIFICANTLY CHANGED THE RATE OF RE-INTERVENTIONS IN THE POSTOPERATIVE COURSE IN COMPARISON WITH CLASSIC NON-ABSORBABLE PROLIFT MESH, PARTICULARLY REGARDING RE-INTERVENTION FOR MESH-RELATED COMPLICATIONS, INCLUDING MESH EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324586 PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention