BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8903924 · Received August 16, 2019

    Report

    Report Number
    2210968-2019-85669
    Event Type
    Injury
    Date Received
    August 16, 2019
    Report Date
    July 22, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 (2012) 36:984¿992 / DOI 10.1007/S00268-012-1508-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: DESARDA VERSUS LICHTENSTEIN TECHNIQUE FOR PRIMARY INGUINAL HERNIA TREATMENT: 3-YEAR RESULTS OF A RANDOMIZED CLINICAL TRIAL. THE PURPOSE OF THIS RANDOMIZED TRIAL WAS TO COMPARED OUTCOMES AFTER HERNIA REPAIR WITH DESARDA (D) AND MESH-BASED LICHTENSTEIN (L) TECHNIQUES. FROM JAN 2005 TO JUN 2009, A TOTAL OF 208 MALE PATIENTS WITH PRIMARY INGUINAL HERNIA WERE RANDOMLY ASSIGNED INTO TWO GROUPS: DESARDA TISSUE-BASED TECHNIQUE (D) (N=105, MEAN AGE 50.2 YEARS) OR MESH-BASED LICHTENSTEIN TECHNIQUE (L) (N=103, MEAN AGE 54.1 YEARS). IN LICHTENSTEIN TECHNIQUE, AN 8 X 12 CM POLYPROPYLENE MESH (PROLENE MESH) WAS TRIMMED TO A FOOT-LIKE SHAPE TO FIT THE INGUINAL FLOOR. THE MESH WAS SUTURED TO THE LIGAMENT OF POUPART USING A NON-ABSORBABLE CONTINUOUS 2/0 SUTURE (PROLENE SUTURE) AND SECURED CRANIALLY USING AN ABSORBABLE 2/0 SUTURE (MAXON). CONTINUOUS NON-ABSORBABLE SUTURE (2/0 PROLENE) WAS USED TO SECURE THE APONEUROTIC STRIP TO THE INGUINAL LIGAMENT LATERALLY, AND THE STRIP WAS SECURED TO THE INTERNAL OBLIQUE MUSCLE MEDIALLY WITH INTERRUPTED MAXON. POSTOPERATIVE COMPLICATIONS INCLUDED RECURRENCES (N=2); MILD PAIN (N=46); CHRONIC PAIN (N=3); TESTICULAR EDEMA AFTER 7 DAYS (N=10); TESTICULAR EDEMA AFTER 30 DAYS (N=6); INGUINAL HEMATOMA (N=7); HEMATOMAS NEEDING DRAINAGE (N=2); ECCHYMOSIS (N=5); SEROMA AFTER 7 DAYS (N=6); AND SEROMA AFTER 30 DAYS (N=8). POSTOPERATIVE COMPLICATIONS ON12-MONTH FOLLOW-UP INCLUDED FOREIGN BODY SENSATION (N=17) AND LOSS OR CHANGE OF SENSATION IN THE OPERATED GROIN (N=42). POSTOPERATIVE COMPLICATIONS ON 24-MONTH FOLLOW-UP INCLUDED FOREIGN BODY SENSATION (N=16) AND LOSS OR CHANGE OF SENSATION IN THE OPERATED GROIN (N=41). POSTOPERATIVE COMPLICATIONS ON 36-MONTH FOLLOW-UP INCLUDED FOREIGN BODY SENSATION (N=16) AND LOSS OR CHANGE OF SENSATION IN THE OPERATED GROIN (N=40). THE RESULTS OF PRIMARY INGUINAL HERNIA REPAIR WITH THE DESARDA AND LICHTENSTEIN TECHNIQUES ARE COMPARABLE AT THE 3-YEAR FOLLOW-UP. THE TECHNIQUE MAY POTENTIALLY INCREASE THE NUMBER OF TISSUE-BASED METHODS AVAILABLE FOR TREATING GROIN HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695275 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention