BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT

    MDR report key: 8300486 · Received February 3, 2019

    Report

    Report Number
    2210968-2019-78683
    Event Type
    Injury
    Date Received
    February 3, 2019
    Report Date
    January 10, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K070224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ULTRAPRO HERNIA PLUG AND ULTRAPRO HERNIA SYSTEM) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: JOURNAL OF SURGICAL RESEARCH JANUARY 2019 (233) 420-425; DOI: HTTPS://DOI.ORG/10.1016/J.JSS.2018.08.034 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A PROSPECTIVE STUDY ON FEMORAL HERNIA REPAIR: IS THE INGUINAL BETTER THAN THE INFRAINGUINAL APPROACH?" AUTHORS: YANYAN XIE, MD, YINGHAN SONG, PHD, DONGYANG MA, MD,FUSHUN JIAN, MD,A SEN ZHANG, MD, ANQING LU, MD, WANG YONG, PHD, AND WENZHANG LEI, MD CITATION: JOURNAL OF SURGICAL RESEARCH JANUARY 2019 (233) 420-425; DOI: HTTPS://DOI.ORG/10.1016/J.JSS.2018.08.034. THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE OUTCOMES OF THE INFRAINGUINAL AND INGUINAL APPROACHES IN THE TREATMENT OF PRIMARY UNILATERAL FEMORAL HERNIAS. A TOTAL OF 80 PATIENTS WITH PRIMARY UNILATERAL FEMORAL HERNIAS UNDERWENT HERNIA REPAIR WITH EITHER INFRAINGUINAL APPROACH (N=40; N=2 MALE AND N=38 FEMALE; MEAN AGE OF 68.8±12.6 YEARS) OR INGUINAL APPROACH (N=40; N=5 MALE AND N=35 FEMALE; MEAN AGE OF 60.6±11.3 YEARS). IN INFRAINGUINAL APPROACH, ULTRAPRO PLUG (UPP) WAS PLACED THROUGH THE FEMORAL CANAL USING FORCEPS. THE ANCHOR OF THE UPP SHOULD BE UNFOLDED AT THE INNER SURFACE OF THE FEMORAL RING BEFORE FIXING THE RIM TO THE INGUINAL LIGAMENT, PECTINEAL LIGAMENT, AND GIMBERNAT LIGAMENT WITH 3-0 ABSORBABLE SUTURE. IN INGUINAL APPROACH, ULTRAPRO HERNIA SYSTEM (UHS) WAS USED AND SUTURED TO THE INGUINAL LIGAMENT AND PUBIC NODULES, THUS PREVENTING DISPLACEMENT. POSTOPERATIVE COMPLICATIONS INCLUDED URINARY RETENTION (N=2 INGUINAL GROUP) TREATED BY URINE CATHETERIZATION; SEROMA (N=1 INFRAINGUINAL GROUP AND N=3 INGUINAL GROUP) TREATED WITHIN 2-4 WEEKS WITH CONSERVATIVE TREATMENT SUCH AS HOT COMPRESS; FOREIGN BODY SENSATION (N=1 INFRAINGUINAL GROUP AND N=3 INGUINAL GROUP); CHRONIC PAIN (N=1 INFRAINGUINAL GROUP AND N=4 INGUINAL GROUP); AND RECURRENCE OF NEWLY DEVELOPED DIRECT HERNIAS (N=1 INFRAINGUINAL GROUP) TREATED BY PREPERITONEAL REPAIR. IN PATIENTS UNDERGOING ELECTIVE PRIMARY FEMORAL HERNIA REPAIR, THE INFRAINGUINAL APPROACH HAS A SIMILAR CLINICAL CURATIVE EFFECT TO THAT OF THE INGUINAL APPROACH. HOWEVER, THE FORMER HAS THE ADVANTAGES OF SIMPLE OPERATION, SHORT OPERATION TIME, AND FEWER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93428 ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention