BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20560147 · Received October 29, 2024

    Report

    Report Number
    2210968-2024-11208
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 3, 2022
    Report Date
    October 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: J. CLIN. MED. 2022, 11, 5856. HTTPS://DOI.ORG/10.3390/JCM11195856.

    Description of Event or Problem · 0

    TITLE: SUB-MUSCULAR DIRECT-TO-IMPLANT IMMEDIATE BREAST RECONSTRUCTION IN PREVIOUSLY IRRADIATED PATIENTS AVOIDING THE USE OF ADM: A PRELIMINARY STUDY. THE AIM OF THIS PAPER IS TO PRESENT A PRELIMINARY EXPERIENCE OF SUB-MUSCULAR PRIMARY DIRECT-TO-IMPLANT BREAST RECONSTRUCTION WITHOUT ACELLULAR DERMAL MATRIX, AFTER SALVAGE MASTECTOMY FOR LOCAL RECURRENCE FOLLOWING PRIOR IRRADIATION. BETWEEN JANUARY 2015 AND DECEMBER 2020, 18 FEMALE PATIENTS WITH AN AVERAGE OF 68 YEARS (RANGE, 50 TO 74) WHO UNDERWENT IMMEDIATE DIRECT-TO-IMPLANT BREAST RECONSTRUCTIONS WITHOUT ACELLULAR DERMAL MATRIX FOLLOWING RADIOTHERAPY AND SALVAGE MASTECTOMY FOR LOCAL RECURRENCE WERE INCLUDED IN THE STUDY. DURING THE BREAST RECONSTRUCTION PROCEDURES, THE NEW INFRAMAMMARY FOLD WAS FIXED WITH PDS 2-0 INTERRUPTED SUTURES TO THE THORACIC FASCIA. THE CONTRALATERAL SIDE WAS APPROACHED ACCORDINGLY IF NECESSARY. SUCTION DRAINS WERE PLACED IN THE SUBCUTANEOUS TISSUE AND THE SUB-MUSCULAR POCKET, AND WERE KEPT IN PLACE UNTIL THE OUTPUT WAS LESS THAN 50 CC IN 24 H. REPORTED COMPLICATIONS INCLUDED WOUND DEHISCENCE (N=4) AND SUPERFICIAL MASTECTOMY FLAP NECROSIS (N=3) INCLUDING A 65-YEAR-OLD FEMALE WHO HAD A SUPERFICIAL NECROSIS OF THE UPPER AND LOWER MASTECTOMY FLAP. IN CONCLUSION, DIRECT-TO-IMPLANT BREAST RECONSTRUCTION FOLLOWING PRIOR IRRADIATION CAN BE CONSIDERED AS AN OPTION IN PATIENTS WHO ARE NOT GOOD CANDIDATES FOR AUTOLOGOUS BREAST RECONSTRUCTION. OUR GENERAL OUTCOMES COMPARED FAVORABLY WITH LITERATURE DATA REGARDING THE USE OF STAGED PROCEDURES, WITH ACCEPTABLE COMPLICATION RATES AND LEVELS OF PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339600 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention