BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 14686784 · Received June 14, 2022

    Report

    Report Number
    2210968-2022-04533
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    October 1, 2019
    Report Date
    June 29, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 INC, 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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? WHAT SURGICAL OR MEDICAL INTERVENTION HAS BEEN PERFORMED? 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. (B)(4): DEVICE NOT RETURNED. CITATION: LABORATORY MEDICINE AND CLINIC, YEAR 2019, MONTH 10, VOLUME 16, PERIOD 20, PAGES 2982-2988.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 6/29/2022 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 INC 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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS?

    Description of Event or Problem · 0

    TITLE: EFFECT OF TRANEXAMIC ACID SEQUENTIAL APPLICATION OF FEMORAL NECK FRACTURE IN ELDERLY PATIENTS ON PERIOPERATIVE BLOOD LOSS AFTER TOTAL HIP ARTHROPLASTY THE OBJECTIVE OF THE STUDY IS TO INVESTIGATE THE CLINICAL EFFECT OF MULTI-CHANNEL AND SEQUENTIAL APPLICATION OF TRANEXAMIC ACID ON BLOOD LOSS IN ELDERLY PATIENTS WITH FEMORAL NECK FRACTURES UNDERGOING TOTAL HIP ARTHROPLASTY. FROM JUNE 2015 TO JUNE 2016, 41 ELDERLY PATIENTS (17 MALES AND 24 FEMALES) WHO UNDERWENT UNILATERAL BIOTYPE TOTAL HIP ARTHROPLASTY WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS: USING TRANEXAMIC ACID SEQUENTIAL TREATMENT AS GROUP A (N = 23), INCLUDING 9 MALES AND 14 FEMALES; USING SALINE TREATMENT AS GROUP B (N = 18), INCLUDING 8 MALES AND 10 FEMALES. DURING THE PROCEDURE, THE JOINT CAPSULE WAS SUTURED WITH ETHIBOND EXCEL MB66 (ETHICON) SUTURE TO REPAIR THE EXTERNAL ROTATOR MUSCLE GROUP AND ITS DEEP JOINT CAPSULE. A COMPETITOR¿S BIOTYPE PROSTHESES WERE USED IN BOTH GROUPS. THE INTRAOPERATIVE BLOOD LOSS AND POSTOPERATIVE DRAINAGE VOLUME OF THE TWO GROUPS OF PATIENTS WERE RECORDED, THE HIDDEN BLOOD LOSS AND TOTAL BLOOD LOSS WERE CALCULATED ACCORDING TO THE HEIGHT, BODY WEIGHT AND HEMATOCRIT BEFORE AND AFTER THE OPERATION, AND THE PATIENTS WITH RELATED COMPLICATIONS AND BLOOD TRANSFUSION WERE OBSERVED. REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE WOUND INFECTION (N=1). IN CONCLUSION, MULTI-CHANNEL AND SEQUENTIAL APPLICATION OF TRANEXAMIC ACID CAN EFFECTIVELY REDUCE BLOOD LOSS IN ELDERLY PATIENTS WITH FEMORAL NECK FRACTURE AND TOTAL HIP ARTHROPLASTY, REDUCE POSTOPERATIVE BLOOD TRANSFUSION RATE, AND DOES NOT INCREASE THE RISK OF POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686999 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention