BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 19756947 · Received July 16, 2024

    Report

    Report Number
    2210968-2024-07294
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    April 9, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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? 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J. CLIN. MED. 13, 2165. HTTPS://DOI.ORG/10.3390/JCM13082165.

    Description of Event or Problem · 0

    TITLE : THE IMPACT OF TECHNICAL INNOVATIONS AND DONOR-SITE MESH REPAIR ON AUTOLOGOUS ABDOMINAL-BASED BREAST RECONSTRUCTION¿A RETROSPECTIVE ANALYSIS THE AIM OF THIS STUDY WAS TO EXAMINE THE POTENTIAL BENEFIT THAT MAY BE ACHIEVED THROUGH THE INTRODUCTION OF TECHNICAL INNOVATIONS AND THE INCORPORATION OF MESH FOR FASCIAL DONOR SITE CLOSURE IN UNI- AND BILATERAL AUTOLOGOUS BREAST RECONSTRUCTION WITH ABDOMINAL TISSUE. WE PERFORMED A RETROSPECTIVE SINGLE-CENTER CHART REVIEW OF 424 CONSECUTIVE PATIENTS WHO UNDERWENT UNILATERAL OR BILATERAL ABDOMINAL-BASED AUTOLOGOUS BREAST RECONSTRUCTION WITH A DIEP OR MS-TRAM FLAP BETWEEN JANUARY 2004 AND DECEMBER 2019. DUE TO INSUFFICIENT FOLLOW-UP DATA, 28 PATIENTS (29 FLAPS) HAD TO BE EXCLUDED FROM FURTHER ANALYSIS. TABLE 1 PROVIDES A SUMMARY OF THE PATIENT DEMOGRAPHIC CHARACTERISTICS. OF THE 396 PATIENTS INCLUDED, 51 PATIENTS (13%) RECEIVED BILATERAL BREAST RECONSTRUCTION. AGES RANGED FROM 31 TO 77 YEARS (MEAN 52 YEARS). A TOTAL OF 73% OF THE PATIENTS UNDERWENT MESH REPAIR WITH A SYNTHETIC TITANIUM-COATED POLYPROPYLENE MESH (TIMESH®, PFM MEDICAL AG, KÖLN, GERMANY), 22% RECEIVED A VICRYL¿ PROLENE COMPOSITE SYNTHETIC MESH (VYPRO®, ETHICON, JOHNSON & JOHNSON, NORDERSTEDT,GERMANY), AND IN 5% OF THE PATIENTS, FURTHER TYPES OF SYNTHETIC MESHES WERE IMPLANTED (PROLENE® (ETHICON), MARLEX® (ETHICON)). THE REPORTED COMPLICATIONS INCLUDED ABDOMINAL HERNIA/BULGING (N=? ), SEROMA (N=?), INFECTION (N=?), HEMATOMA/BLEEDING (N=?), UMBILICAL NECROSIS (N=?), AND WOUND DEHISCENCE (N=?) IN CONCLUSION, RECENT TECHNOLOGICAL ADVANCEMENTS DEVELOPED OVER THE PAST FEW DECADES HAVE MADE A SUBSTANTIAL IMPACT ON DECREASING SURGICAL DURATION AND ENHANCING PROCEDURE SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504403 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other