BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP UNKNOWN PRODUCT

    MDR report key: 15476322 · Received September 24, 2022

    Report

    Report Number
    2210968-2022-07852
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    January 1, 2021
    Report Date
    September 23, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (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 CITE: INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH & ALLIED SCIENCES, 2021, 10(3):25-32, HTTPS://DOI.ORG/10.51847/HLAZTF0Q1U. 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 (SECURESTRAP, ULTRAPRO MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? PATIENT DEMOGRAPHICS? ADVERSE EVENTS ASSOCIATED WITH ULTRAPRO MESH DEVICE REPORTED VIA MW # 2210968-2022-07851; ADVERSE EVENTS ASSOCIATED WITH SECURESTRAP DEVICE REPORTED VIA MW #.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PECULIARITIES OF PRE-PERITONEAL HERNIOPLASTY IN SURGICAL TREATMENT OF VENTRAL HERNIAS OF LOWER AND MEDIAN LOCALIZATION. THE PURPOSE OF THIS RESEARCH WORK IS TO ANALYZE AND SUBSTANTIATE THE ADVANTAGES OF THE LAPAROSCOPIC HERNIOPLASTY METHOD, ITS IMPROVEMENT, TO IMPROVE THE RESULTS OF SURGICAL TREATMENT OF HERNIAS OF MEDIAL AND LOWER LOCALIZATION. IN THE PROCESS OF THIS RESEARCH, WE USED A COMPARISON METHOD BASED ON THE SURGICAL INTERVENTION BY TAPP AND SUBLAY PERFORMED ON 405 PATIENTS. AMONG THE TOTAL NUMBER OF PATIENTS, 286 WERE FEMALE AND 119 WERE MALE. THE MEAN BMI AMONG ALL PATIENTS WAS 29 T. THE LAPAROSCOPIC TECHNIQUE IN THE TREATMENT OF VENTRAL HERNIA WAS INTRODUCED IN 2012 BY IPOM AND TAPP. ULTRAPRO J & J (USA) WAS USED FOR HERNIOPLASTY. MESH PROSTHESIS FIXATION AND PERITONEALIZATION WERE PERFORMED USING ETHICON SECURESTRAP. REPORTED COMPLICATIONS INCLUDED SEROMA (N=9), TRANSPLANT REJECTION (N=2), THROMBOPHLEBITIS (N=3), HERNIA RECURRENCE (N=2), THROMBOEMBOLISM OF SMALL BRANCHES OF THE PULMONARY ARTERY (N=1), ADHESIVE INTESTINAL OBSTRUCTION, NECROSIS OF THE NAVEL SKIN. IN CONCLUSION THE DEVELOPMENT AND IMPLEMENTATION OF LAPAROSCOPIC TECHNIQUES SHOW SIGNIFICANT ADVANTAGES IN COMPARISON WITH OPEN LAPAROTOMY METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651557 SECURESTRAP UNKNOWN PRODUCT IMPLANTABLE STAPLE GDW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention