BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8501431 · Received April 10, 2019

    Report

    Report Number
    2210968-2019-80241
    Event Type
    Injury
    Date Received
    April 10, 2019
    Report Date
    March 13, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: CHIRURGIA ITALIANA [ITALIAN SURGERY] 2004 - VOL. 56 NO. 1 PP 127-134. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: TREATMENT OF INGUINAL HERNIA WITH THE PROLENE HERNIA SYSTEM® (P.H.S.) THIS RETROSPECTIVE STUDY AIMED TO SPECIFY THE INDICATIONS AND TECHNICAL ASPECTS OF THE METHOD AND EVALUATE THE EFFICACY OF PROLENE HERNIA SYSTEM® (P.H.S.). BETWEEN JANUARY 1999 TO JULY 2003, 156 INGUINAL HERNIORRAPHIES WERE PERFORMED WITH THE P.H.S. IN 152 PATIENTS (MALE N=143 AND FEMALE N=9) WITH MEAN AGE OF 62.4 YEARS (RANGING FROM 25-94). THE UNDERLAY SECTION OF THE PROSTHETIC DEVICE IS INSERTED AND HELD AT ITS MEDIAL AND LATERAL ENDS BY TWO KLEMMER-TYPE CURVED FORCEPS. THE TRANSVERSALIS FASCIA IS THEN CLOSED BY JOINING IT TO THE SIDES OF THE CONNECTOR WITH TWO POLYPROPYLENE SUTURES, SO THAT THE TWO COMPONENTS OF THE DEVICE (ONLAY AND UNDERLAY) ARE PLACED ON TWO SEPARATE PLANES SEPARATED BY THE TRANSVERSALIS FASCIA. THE SUPERFICIAL SECTION, LOCATED IN THE SUB-FASCIAL SPACE, IS SECURED WITH TWO SUTURES IN POLYPROPYLENE, PLACED RESPECTIVELY ON THE RECTUS MUSCLE FASCIA (1 CENTIMETRE MEDIALLY TO THE PUBIC TUBERCLE) AND IN THE MIDDLE OF THE INGUINAL LIGAMENT. THE INCISION MADE ON THE SUPERFICIAL MESH TO ALLOW THE FUNICULUS TO PASS THROUGH IS CLOSED BY JOINING THE ¿TAILS¿ TO THE INGUINAL LIGAMENT WITH A FURTHER POLYPROPYLENE SUTURE. FINALLY, THE MEDIAL PORTION OF THE MESH IS ANCHORED TO THE TRANSVERSE MUSCLE ARCH WITH A SUTURE MADE OF MATERIAL THAT REABSORBS SLOWLY. COMPLICATIONS INCLUDED HAEMOTOMAS (N=7), SEROMAS (N=4), PERSISTENT INGUINAL AND CRURAL PAIN (N=5) WHICH ALL REGRESSED SPONTANEOUSLY WITHIN A YEAR AFTER SURGERY AND A RECURRENT HERNIA (N=1). IN CONCLUSION, HERNIA REPAIR WITH THE P.H.S. IS A VALID ALTERNATIVE TO OTHER COMMON TECHNIQUES BUT THEY SUGGEST ITS USE PARTICULARLY IN PRIMARY HERNIAS WITH MAJOR RELAXATION OF THE POSTERIOR INGUINAL WALL OF THE INGUINAL CANAL OR OF THE ENTIRE MYOPECTINEAL ORIFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294705 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention