BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8906829 · Received August 19, 2019

    Report

    Report Number
    2210968-2019-85743
    Event Type
    Injury
    Date Received
    August 19, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 (2012); 16:133¿144. DOI: 10.1007/S10029-011-0883-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: COMPARISON OF NON-MESH (DESARDA) AND MESH (LICHTENSTEIN) METHODS FOR INGUINAL HERNIA REPAIR AMONG BLACK AFRICAN PATIENTS: A SHORT-TERM DOUBLE-BLIND RCT. THE PURPOSE OF THIS STUDY IS TO COMPARE EARLY CLINICAL OUTCOMES OF DESARDA¿S REPAIR WITH THOSE FOLLOWING THE LICHTENSTEIN TECHNIQUE FOR THE TREATMENT OF PRIMARY INGUINAL HERNIAS AMONG ADULT AFRICAN PATIENTS. BETWEEN APRIL AND JULY 2009, THIS SINGLE CENTRE DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL INCLUDES 101 PATIENTS (88 MALE AND 13 FEMALE; MEDIAN AGE: 32 YEARS; AGE RANGE: 18-82 YEARS) WHO PRESENTED WITH A PRIMARY, REDUCIBLE INGUINAL OR INGUINO-SCROTAL HERNIA. THE PATIENTS WERE RANDOMIZED INTO TWO GROUPS: IN THE MESH GROUP, 51 PATIENTS (42 MALE AND 9 FEMALE; MEDIAN AGE: 40.0) WERE INCLUDED IN THE LICHTENSTEIN ARM AND IN THE NON-MESH GROUP, 50 PATIENTS (46 MALE AND 4 FEMALE; MEDIAN AGE: 28.5) WERE INCLUDED IN THE DESARDA ARM. IN LICHTENSTEIN TECHNIQUE, THE PROLINE MESH (ETHICON) IS FASHIONED TO FIT THE POSTERIOR WALL OF THE INGUINAL CANAL. THE MESH IS THEN SUTURED TO THE FIBRO-PERIOSTEUM OF THE PUBIC BONE USING INTERRUPTED POLYPROPYLENE 3/0 PROLINE SUTURE (ETHICON). IN DESARDA TECHNIQUE, THE UPPER (MEDIAL) LEAF OF THE EXTERNAL OBLIQUE APONEUROSIS (EOA) IS SUTURED TO THE INGUINAL LIGAMENT FROM THE PUBIC TUBERCLE TO THE DEEP INGUINAL RING USING 2/0 ETHILON INTERRUPTED SUTURES (ETHICON). THE FIRST 1¿2 SUTURES ARE TAKEN IN THE ANTERIOR RECTUS SHEATH. THE LAST SUTURE IS TAKEN SO AS TO NARROW THE DEEP RING SUFFICIENTLY WITHOUT CONSTRICTING THE SPERMATIC CORD. REPORTED COMPLICATIONS IN THE MESH GROUP INCLUDED PAIN 1-2 H AND ON 3RD POD (N-?). INTRAOPERATIVE COMPLICATIONS IN THE MESH GROUP INCLUDED ILIOHYPOGASTRIC NERVE INJURY (N-1); ON POD 7 REPORTED COMPLICATIONS INCLUDED PAIN ON POD 7 (N-?), SCROTAL OEDEMA (N-4) WHICH WERE SUCCESSIVELY MANAGED CONSERVATIVELY, SCROTAL HAEMATOMA (N-2) WHICH WERE SUCCESSIVELY MANAGED CONSERVATIVELY, SEROMA (N-1); AND ON POD 14, REPORTED COMPLICATIONS INCLUDED SCROTAL OEDEMA (N-3) WHICH WERE SUCCESSIVELY MANAGED CONSERVATIVELY, GROIN PAIN/ NEUROPATHIC TYPE PAIN (N-4), AND PAIN ON POD 14 (N-?) REPORTED COMPLICATIONS IN THE NON-MESH GROUP INCLUDED PAIN 1-2 H AND ON 3RD POD (N-?). INTRAOPERATIVE COMPLICATIONS IN THE NON-MESH GROUP INCLUDED ILIOINGUINAL NERVE INJURY (N-1) AND ILIOHYPOGASTRIC NERVE INJURY (N-1); ON POD 7, REPORTED COMPLICATIONS INCLUDED PAIN ON POD 7 (N-?), SCROTAL OEDEMA (N-4) WHICH WERE SUCCESSIVELY MANAGED CONSERVATIVELY, SCROTAL HAEMATOMA (N-1) WHICH WERE SUCCESSIVELY MANAGED CONSERVATIVELY; AND ON POD 14, REPORTED COMPLICATIONS INCLUDED SCROTAL OEDEMA (N-4) WHICH WERE SUCCESSIVELY MANAGED CONSERVATIVELY, HYDROCOELE (N-1), NUMBNESS (PUBIC) (N-1), GROIN PAIN/ NEUROPATHIC TYPE PAIN (N-1), AND PAIN ON POD 14 (N-?). TWO PARTICIPANTS WITH MODERATELY SIZED SCROTAL HAEMATOMAS IMPROVED AFTER NEEDLE ASPIRATION. THE MESH IS INVADED RAPIDLY BY FIBROBLASTS THAT FILL UP THE PORES IN THE MESH WHICH COULD RESULT IN DELAYED ABSORPTION OF THE SEROUS FLUID ACCUMULATING IN THE WOUND AFTER THE OPERATION, LEADING TO SEROMA FORMATION. IN CONCLUSION, THE RESULTS OF THE STUDY SHOWED THAT THE EFFECTIVENESS OF THE DESARDA TECHNIQUE WITH RESPECT TO INFLUENCING THE EARLY CLINICAL OUTCOMES OF HERNIA REPAIR IS SIMILAR TO THAT OF THE LICHTENSTEIN METHOD. HOWEVER, THE OPERATOR IN THIS STUDY SHOWED THAT THE DESARDA REPAIR REQUIRES SIGNIFICANTLY SHORTER OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700418 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention