BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8899362 · Received August 15, 2019

    Report

    Report Number
    2210968-2019-85645
    Event Type
    Injury
    Date Received
    August 15, 2019
    Report Date
    July 18, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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: HERNIA (2011) 15:309¿313; DOI 10.1007/S10029-011-0783-3; PUBLISHED ONLINE: 23 JANUARY 2011. (B)(4).

    Description of Event or Problem · 1

    TITLE: PROSPECTIVE RANDOMIZED EVALUATION OF PROPHYLACTIC ANTIBIOTIC USAGE IN PATIENTS UNDERGOING TENSION FREE INGUINAL HERNIOPLASTY. THIS PROSPECTIVE RANDOMIZED DOUBLE BLINDED STUDY AIMED TO ASSESS USEFULNESS OF ANTIBIOTIC PROPHYLAXIS IN INGUINAL HERNIOPLASTY. BETWEEN JULY 2006 AND APRIL 2010, 98 PATIENTS WERE RANDOMLY DIVIDED INTO TWO GROUPS. FIFTY PATIENTS (AGE 43.4±19.8, MALE N= 48, FEMALE N=2) IN GROUP A RECEIVED A SINGLE DOSE OF INTRAVENOUS AMOXICILLIN AND CLAVULANIC ACID, AND 48 PATIENTS (AGE 44.5±20.5, MALE N=48) IN GROUP P RECEIVED AN EQUAL VOLUME OF NORMAL SALINE PLACEBO BY INTRAVENOUS BOLUS 30 MIN BEFORE THE INDUCTION OF ANESTHESIA. A STANDARD MESH HERNIOPLASTY WAS PERFORMED. POLYPROPYLENE MESH (PROLENE MESH, ETHICON) WAS ANCHORED WITH INTERRUPTED POLYPROPYLENE SUTURE TO CONJOINT TENDON, PUBIC TUBERCLE, INGUINAL LIGAMENT AND FASCIA TRANSVERSALIS BEYOND THE DEEP RING. THE SKIN WAS CLOSED USING SKIN STAPLES THAT WERE REMOVED AFTER COMPLETE WOUND HEALING. COMPLICATIONS INCLUDED DEEP SURGICAL SITE INFECTION (N=1) IN GROUP A AND DEEP SURGICAL SITE INFECTION (N=1) IN GROUP P. ANTIBIOTIC TREATMENT OF WOUND INFECTION WAS SUCCESSFUL IN ALL PATIENTS. IN CONCLUSION, PROPHYLACTIC ANTIBIOTIC USAGE IN PATIENTS UNDERGOING TENSION FREE INGUINAL HERNIOPLASTY DID NOT SHOW ANY STATISTICALLY SIGNIFICANT BENEFICIAL EFFECTS IN REDUCTION OF SURGICAL SITE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691861 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention