BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 19001076 · Received March 28, 2024

    Report

    Report Number
    2210968-2024-03611
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    October 14, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. RELATED EVENTS CAPTURED VIA 2210968-2024-03602, 2210968-2024-03603, 2210968-2024-03604, 2210968-2024-03605, 2210968-2024-03606, 2210968-2024-03607, 2210968-2024-03608, 2210968-2024-03609, 2210968-2024-03610. CITATION: JOURNAL OF CARDIOTHORACIC SURGERY, (2023); 18 (293): PAGES 1-9. HTTPS://DOI.ORG/10.1186/S13019-023-02369-0.

    Description of Event or Problem · 0

    TITLE: SURGICAL TREATMENT OF SEVERE BENIGN TRACHEAL STENOSIS. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO PRESENT CLINICAL EXPERIENCES REGARDING SURGICAL TREATMENT OF PATIENTS WITH SEVERE CICATRICIAL TRACHEAL STENOSIS. BETWEEN JANUARY 2008 TO MARCH 2020, A TOTAL OF 14 PATIENTS (12 MALES AND 2 FEMALES WITH MEAN AGE OF 43.2 ± 13.9 YEARS) UNDERWENT TRACHEAL RESECTION AND RECONSTRUCTION WERE INCLUDED IN THIS STUDY. THIS STUDY WAS TREATED WITH PROLENE 3-0 AND VICRYL 3-0 SUTURES. END-TO-END ANASTOMOSIS OF TRACHEA WAS PERFORMED IN 13 CASES AND THE ANASTOMOSIS BETWEEN TRACHEA AND CRICOTHYROID MEMBRANE WAS PERFORMED IN ONE CASE. ABSORBABLE AND UNABSORBABLE SUTURES WERE USED FOR THE ANTERIOR AND POSTERIOR ANASTOMOSES, RESPECTIVELY. POSTOPERATIVE NECK ANTEFLEXION WAS MAINTAINED BY A SUTURE BETWEEN THE CHIN AND SUPERIOR CHEST WALL. THE RELEVANT DATA OF THE 14 PATIENTS WERE RETROSPECTIVELY REVIEWED, AND THE OPERATION TIME, BLOOD LOSS, POSTOPERATIVE HOSPITAL STAY, POSTOPERATIVE COMPLICATIONS AND FOLLOW-UP WERE RETRIEVED. THE MEAN FOLLOW-UP PERIOD WAS 17.9 ± 10.6 MONTHS. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: -PATIENT 6, (MALE, 30 YO) ANASTOMOTIC FISTULA TREATMENT: DRAINAGE AND ANTI-INFECTION IN CONCLUSION, THE STRATEGIES OF ANESTHESIA, MECHANICAL VENTILATION, IDENTIFICATION OF STENOSIS LESION, THE ¿HYBRID¿ SUTURES AND POSTOPERATIVE ANTEFLEXION ARE CRITICAL TO BE OPTIMIZED FOR SUCCESSFUL POSTOPERATIVE RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720694 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention