BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8951529 · Received August 30, 2019

    Report

    Report Number
    2210968-2019-86451
    Event Type
    Injury
    Date Received
    August 30, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURG RADIOL ANAT (2002) 24: 102¿107; DOI 10.1007/S00276-002-0006-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ANATOMICAL VARIATIONS OF THE INGUINAL NERVES AND RISKS OF INJURY IN 110 HERNIA REPAIRS. THE AIM OF THIS STUDY WAS TO IDENTIFY THE ANATOMICAL VARIATIONS IN THE INGUINAL COURSE OF THE ILIOINGUINAL NERVE (IIN) AND THE ILIOHYPOGASTRIC NERVE (IHN) DURING OPERATIVE REPAIR OF INGUINAL HERNIAS. BETWEEN 01MAR1997 AND 31MAY1999, 105 ADULT PATIENTS HAD ELECTIVE REPAIR OF 110 PRIMARY INGUINAL HERNIAS (MALE=103, AGE RANGE 20-88 YEARS, MEAN AGE 58.5 YEARS; FEMALE= 2, AGE RANGE 78-80 YEARS). IN THE PROCEDURE, AFTER EXCISING AN INDIRECT SAC OR PLICATING THE TRANSVERSALIS FASCIA OVER A DIRECT ONE, A 6X10 CM PROLENE MESH (ETHICON) WAS ROUTINELY USED FOR REPAIR AND FREQUENTLY SLIT AT SOME POINT ALONG ITS MEDIAL AGE FOR 1-2 CM TO ALLOW PASSAGE OF IHN. IMMEDIATE POSTOPERATIVE COMPLICATIONS INCLUDED WOUND INFECTION (N=1) AND SCROTAL HEMATOMA (N=2). IT IS CONCLUDED THAT ANATOMICAL VARIATIONS IN THE INGUINAL COURSE OF THE IIN AND THE IHN ARE EXTREMELY COMMON BUT READILY IDENTIFIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745778 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention