BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE 3D PATCH MESH UNKNOWN PRODUCT

    MDR report key: 8385027 · Received March 3, 2019

    Report

    Report Number
    2210968-2019-79208
    Event Type
    Injury
    Date Received
    March 3, 2019
    Report Date
    February 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    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: WORLD J SURG (2006) 30: 1055¿1062; DOI: 10.1007/S00268-005-0602-Z. PLEASE SEE REFERENCED ARTICLE ATTACHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: FEASIBILITY OF PRIMARY INGUINAL HERNIA REPAIR WITH A NEW MESH. THE AIM OF THE PRESENT STUDY WAS TWOFOLD: TO EVALUATE THE FEASIBILITY OF PRIMARY INGUINAL HERNIA REPAIR WITH OPEN TRABUCCO¿S TECHNIQUE USING THE NEW POLYPROPYLENE 3D PATCH AND TO EVALUATE THE QUALITY OF THE TREATMENT PROTOCOL IN THE DAY-SURGERY SETTING. BETWEEN OCT2003 AND FEB2005, 56 PATIENTS WITH PRIMARY MONOLATERAL UNCOMPLICATED REDUCIBLE INGUINAL HERNIA UNDERWENT REPAIR USING TRABUCCOS TECHNIQUE AND PROLENE 3D PATCH. IN THE PROCEDURE WHEN PRESHAPED OVERLAY TYPE OF PROLENE 3D PATCH WAS USED, IT WAS LAID ON THE FLATTENED INGUINAL FLOOR AND ONCE IN PLACE, IT WAS HELD IN POSITION AND PULLED ON THE FREE END OF THE LOOPED SUTURE TO FLATTEN THE DIAMOND-SHAPED PLUG SO THAT IT WOULD NOT FILL THE DEFECT AND LIE FLAT BELOW THE TRANSVERSALIS FASCIA LAYER. WHEN THE EXTENDED OVERLAY TYPE WAS USED, TRANSVERSAL SECTION ON THE MEDIAL SIDE OF THE PATCH WAS PERFORMED, BOTH PATCH TAILS WERE SUTURED AROUND THE SPERMATIC CORD WITH ONE STITCH. POSTOPERATIVE MEAN VAS PAIN SCORE WAS 2.8 AT 24 HOURS, 1.8 AT 72 HOURS, 0.9 AT 7 DAYS, 0.3 (N=13) AT 15 DAYS AND 0.04 (N=2) AT 30 DAYS; TREATED WITH ANALGESIC DRUGS (KETOROLAC) INCLUDING 4 PILLS (N=2), 2 PILLS (N=3), AND ONE PILL (N=14). THIRTY SEVEN PATIENTS DID NOT USED ANALGESIC DRUGS. COMPLICATIONS INCLUDED SEROMA (N=2) TREATED BY SINGLE NEEDLE ASPIRATION AND VOIDING PROBLEM (N=1) AIDED TO EMPTY THE BLADDER AFTER OPERATION. THE TENSION-FREE AND SUTURELESS HERNIA REPAIR TECHNIQUE DESCRIBED, BASED ON THE USE OF THE PROLENE 3D PATCH, IS A SAFE OPERATION, SIMPLE TO PERFORM, AND IT CAN BE DONE ON AN OUTPATIENT BASIS WITH A LOW COMPLICATION RATE, A LOW LEVEL OF PAIN, AND AN EXCELLENT QUALITY OF LIFE THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178227 PROLENE 3D PATCH MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention