BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 14214501 · Received April 26, 2022

    Report

    Report Number
    2210968-2022-02987
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    November 17, 2019
    Report Date
    April 26, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 (ETHILON SUTURE)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 (ETHILON SUTURE) 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? 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION CITE: DOI: 10.21608/OMX.2019.17876.1040.

    Description of Event or Problem · 0

    TITLE: EVALUATION OF THE ROLE OF GRACILIS FREE FLAP IN RECONSTRUCTION OF OROFACIAL DEFECTS. THE AUTHORS REPORT THEIR EXPERIENCE WITH THE FREE GRACILIS MUSCLE FLAP IN ELEVEN PATIENTS WHO UNDERWENT RECONSTRUCTION IN THE HEAD AND NECK REGION FOR A VARIETY OF INDICATIONS. THIS STUDY INCLUDED ELEVEN CASES WITH CHALLENGING SOFT TISSUE DEFECTS IN THE ORO-FACIAL REGION OF VARIOUS ETIOLOGIC FACTORS, WITHOUT AGE OR SEX LIMITATIONS. ALL PATIENTS WERE ADMITTED TO THE DEPARTMENT OF MAXILLO-FACIAL AND PLASTIC SURGERY, FACULTY OF DENTISTRY, ALEXANDRIA UNIVERSITY, EGYPT. 5000 IU HEPARIN WAS GIVEN INTRAVENOUSLY AND ANASTOMOSIS OF THE RECIPIENT AND DONOR VESSELS WAS DONE USUALLY STARTING WITH THE ARTERY USING 80/ TO 90/ ETHILON SUTURE ETHICON, THEN THE VEIN WAS ANASTOMOSED USING ETHILON ETHICON. REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE ARTERIAL THROMBOSIS (N=1) , POST-OPERATIVE HEMATOMA (N=1), WOUND DEHISCENCE (N=2). IN CONCLUSION FOR DIFFICULT RECONSTRUCTION IN THE HEAD AND NECK REGION, THE FREE GRACILIS MUSCLE FLAP OFFERS A NUMBER OF ADVANTAGES, INCLUDING RELIABLE VASCULAR ANATOMY, RELATIVELY GREAT PLASTICITY AND A CONCEALED DONOR AREA. THUS THIS TYPE OF FLAP OFFERS A VALUABLE OPTION WHENEVER AN AESTHETICALLY AND FUNCTIONAL PLEASING RESULT IS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591420 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention