BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7936191 · Received October 4, 2018

    Report

    Report Number
    2210968-2018-76329
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    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. 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: JPMA 67: 24; 2017 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: HERNIOPLASTY: TENSION FREE MESH REPAIR VERSUS MAYO¿S REPAIR FOR UMBILICAL HERNIAS" AUTHOR: NAZIR AHMED TUNIO; CITATION: JPMA 67: 24; 2017. THIS COMPARATIVE STUDY AIMED TO COMPARE TWO DIFFERENT TECHNIQUES OF REPAIRING UMBILICAL HERNIA. FROM APR 2009 TO DEC 2011, 86 PATIENTS (N=18 MALE AND N=68 FEMALE; AGE RANGED OF 25-65 YEARS) WITH UMBILICAL HERNIAS WERE RANDOMLY ALLOCATED GROUP A ¿ TENSION FREE MESH REPAIR (N=43) AND GROUP B ¿ MAYO¿S REPAIR (N=43). IN GROUP A, PROLENE MESH WAS USED TO COVER THE DEFECT AND PLACED OVER THE ANTERIOR RECTUS SHEATH, ANCHORED BY PROLENE 2/0 IN AN ONLAY FASHION. IN GROUP B, CLASSICAL STEPS WERE APPLIED IN WHICH TRANSVERSE DOUBLE-BREASTING REPAIR WITH NON-ABSORBABLE SUTURE MATERIAL PROLENE NO 1 WAS USED. POSTOPERATIVELY, COMPLICATIONS INCLUDED SEROMA (N=3 GROUP A; N=1 GROUP B), HAEMATOMA (N=1 GROUP A; N=2 GROUP B) AND WOUND INFECTION (N=2 GROUP A; N=4 GROUP B); WHICH WERE ALL MANAGED CONSERVATIVELY. ON BOTH GROUPS, RECURRENCE (N=1 GROUP A; N=3 GROUP B) WAS ALSO NOTED AFTER FOLLOW-UP OF 36 MONTHS. ON THE BASIS OF SHORT HOSPITAL STAY, EARLY RETURN TO NORMAL ACTIVITY, OVERALL MINIMUM COMPLICATIONS AND LESS RECURRENCE RATE, THE TENSION FREE MESH REPAIR WAS FOUND TO BE SUPERIOR THAN MAYO'S REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775179 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention