BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH UNKNOWN PRODUCT

    MDR report key: 16229968 · Received January 23, 2023

    Report

    Report Number
    2210968-2023-00460
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    January 20, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-00459 AND 2210968-2023-00460. CITATION: HTTPS://DX.DOI.ORG/10.21037/TCR-21-2143.

    Description of Event or Problem · 0

    TITLE: THE SIZE AND STERNAL INVOLVEMENT OF CHEST WALL RESECTIONS FOR MALIGNANT DISEASE PREDICT POSTOPERATIVE MORBIDITY. THE OBJECTIVE OF THIS STUDY IS TO DETERMINED THE IMPACT OF CHEST WALL RESECTION SIZE AND LOCATION ON PATIENT SHORT AND LONG-TERM POSTOPERATIVE OUTCOMES. ALL CONSECUTIVE PATIENTS WHO UNDERWENT RESECTIONS/RECONSTRUCTIONS FOR CHEST WALL TUMORS BETWEEN 2003 AND 2018. THE IMPACT OF CHEST WALL RESECTION SIZE AND LOCATION AND RECONSTRUCTION ON PERIOPERATIVE MORBIDITY/MORTALITY AND ONCOLOGICAL OUTCOME WERE EVALUATED FOR EACH PATIENT. BONY CHEST WALL RECONSTRUCTION WAS ACHIEVED WITH SYNTHETIC MATERIAL (80 CASES, 86%) USING MESHES ALONE (VICRYL/MERSILENE, N=21), REPORTED COMPLICATIONS INCLUDED SYNTHETIC MATERIAL INFECTION (N=5), WOUND DEHISCENCE (N=4), SEROMA (N=4) , NECROSIS OF THE FLAP (N=2), PAIN (N=7), ATELECTASIS (N=6) IN CONCLUSION CHEST WALL RESECTIONS PRESENT GOOD LONG-TERM ONCOLOGICAL OUTCOMES. A RESECTION SIZE ABOVE 114 CM2 AND THE INVOLVEMENT OF THE STERNUM ARE SIGNIFICANTLY ASSOCIATED WITH HIGHER RATES OF POSTOPERATIVE PNEUMONIA/ATELECTASIS. THIS SUBGROUP OF PATIENTS SHOULD HAVE REINFORCED PERIOPERATIVE PHYSICAL THERAPY PROTOCOLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407675 MERSILENE POLYESTER FIBER MESH UNKNOWN PRODUCT MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention