BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 11434231 · Received March 8, 2021

    Report

    Report Number
    2210968-2021-02071
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    December 12, 2012
    Report Date
    February 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: MED & PHARM J CHIN PLA, VOL. 25, NO. 3, MAR. 2013; DOI: 10.3969/J.ISSN.2095-140X.2013.03.005. PLEASE SEE ARTICLE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ULTRAPRO HERNIA SYSTEM IN APPLICATION OF TENSION-FREE INGUINAL HERNIA NEOPLASTY. THE OBJECTIVE OF THIS STUDY WAS TO OBSERVE THE EFFECT OF ULTRAPRO HERNIA SYSTEM (UHS) IN APPLICATION OF TENSION-FREE INGUINAL HERNIA NEOPLASTY. FROM MARCH 2011 TO MARCH 2012, 218 PATIENTS WITH INGUINAL HERNIA WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: 120 PATIENTS (MALE=119, FEMALE=1; AGE RANGE=57.3 ± 17.4 YEARS) UNDERWENT TENSION-FREE HERNIOPLASTY USING UHS (ETHICON) (THE UHS GROUP) AND 98 PATIENTS (MALE=97, FEMALE=1; AGE RANGE=59.1 ± 16.7 YEARS) UNDERWENT MESH PLUG HERNIOPLASTY (THE MESH PLUG GROUP). DURING THE PROCEDURE IN THE UHS GROUP, AFTER THE TRANSVERSALIS FASCIA WAS CUT OPEN, THE PREPERITONEAL SPACE WAS FULLY SEPARATED SO AS TO ACCOMMODATE THE LOWER PATCH, THE UPPER PATCH WAS FOLDED IN HALF AND CLAMPED WITH FORCEPS, AND THE MESH CONNECTING PART WAS ALIGNED WITH THE HERNIA RING DEFECT IN THE PREPERITONEAL SPACE AND THE LOWER PATCH WAS INSERTED AND WAS FLATTENED AS FAR AS POSSIBLE, AND THE SPERMATIC CORD WAS PUT INTO THE OPENING ON THE UPPER LATERAL EDGE OF THE UPPER PATCH AND FIXED WITH THE SURROUNDING AREA USING 3-5 STITCHES. FINALLY, THE INCISION WAS SUTURED LAYER BY LAYER AND BANDAGED UNDER PRESSURE. REPORTED COMPLICATIONS INCLUDED SCROTAL EDEMA (HEMATOMA) (N=6); INCISION SEROMA (N=3); INCISION INFECTION (N=1); FOREIGN BODY SENSATION (N=9); MILD POSTOPERATIVE PAIN (N=?). IN CONCLUSION, UHS CAN BE ANATOMICALLY ADAPTED TO THE NEED OF REPAIRING THE AUGMENTATION OF PECTINEUS PORE. THE APPLICATION OF UHS IN THE REPAIR OF INGUINAL HERNIA HAS BETTER POSTOPERATIVE RECOVERY, SHIRTER HOSPITAL STAY, AND LIGHTER FOREIGN BODIES SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333929 ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention