BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 23693015 · Received December 2, 2025

    Report

    Report Number
    2210968-2025-13370
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    March 31, 2023
    Report Date
    December 2, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. 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: FRONT SURG. 2023 MAR 31;10:1150254. HTTPS://DOI.ORG/10.3389/FSURG.2023.1150254 PMID: 37066017; PMCID: PMC10102629.

    Description of Event or Problem · 0

    TITLE: NOT ONLY ACUTE RESPIRATORY FAILURE: COVID-19 AND THE POST-INTUBATION/TRACHEOSTOMY UPPER AIRWAYS LESIONS. THE PURPOSE OF THIS PROSPECTIVE STUDY IS TO REPORT OUR EARLY EXPERIENCE IN ENDOSCOPIC AND/OR SURGICAL MANAGEMENT OF PI/T UPPER AIRWAYS INJURIES OF PATIENTS SURVIVING COVID-19 CRITICAL ILLNESS. FROM MARCH 2020 TO FEBRUARY 2022. A TOTAL OF 13 PATIENTS WERE INCLUDED IN THE STUDY. (8 MALES, 5 FEMALES). AGE RANGED FROM 37 TO 76 YEARS ( 61.9 PLUS OR MINUS 12.2). THE TWO 2/0 POLYGLACTIN (VICRYL; ETHICON, INC., SOMERVILLE, NJ, USA) TRACTION SUTURES WERE PLACED IN THE LOWER TRACHEAL TRACT AND TO THE LARYNX, RESPECTIVELY, THE POSTERIOR ANASTOMOSIS WAS CARRIED OUT FIRST THROUGH A 4/0 POLYDIOXANONE (PDS; ETHICON, INC., SOMERVILLE, NJ, USA) CONTINUOUS SUTURE ON THE MEMBRANOUS. THE LATERO-ANTERIOR CARTILAGINOUS PARS WAS SUTURED WITH INTERRUPTED 3/0 VICRYL STITCHES. REPORTED COMPLICATIONS: 2/0-3/0 POLYGLACTIN (VICRYL; ETHICON). 4/0 POLYDIOXANONE (PDS; ETHICON). -EXPERIENCED A SMALL (<5 MM) OESOPHAGEAL SUTURE LEAK (N=1) TREATMENT: MANAGED BY USING ENDOSCOPIC THROUGH-THE-SCOPE CLIPS (TTSC). EXPERIENCED A TEF RELAPSE (N=1) TREATMENT: SUCCESSFULLY MANAGED BY REDO-SURGERY. BACTERIAL INFECTION OF THE CERVICOTOMY (N=1) TREATMENT: WITH LOCAL MEDICATIONS AND SYSTEMIC ANTIBIOTIC THERAPY. -POSTOPERATIVE LOW-GRADE LARYNGEAL OEDEMA (N=2) TREATMENT: SUCCESSFULLY MANAGED BY LOW-DOSE SYSTEMIC CORTICOSTEROIDS AND DELAYED EXTUBATION. -DEVELOPED NON-OBSTRUCTIVE POSTOPERATIVE GRANULATION TISSUE AT THE ANASTOMOSIS (N=1) TREATMENT: SUCCESSFULLY REGRESSED WITH MEDICAL THERAPY INCLUDING INHALED BECLOMETASONE AND LOW-DOSE SYSTEMIC CORTICOSTEROIDS. - POST-TREATMENT RELAPSE WAS EXPERIENCED (N=9) CASES, REQUIRING REPEATED RIGID BRONCHOSCOPY PROCEDURES (N=5) AND SURGERY (TRACHEAL RESECTION/ANASTOMOSIS) (N=4) FOR DEFINITIVE RESOLUTION OF THE STENOSIS. IN CONCLUSIONS, ENDOSCOPIC AND SURGICAL TREATMENT IS CURATIVE IN THE MAJORITY OF PATIENTS AND SHOULD ALWAYS BE CONSIDERED IN PI/T UPPER AIRWAYS LESIONS AFTER COVID-19 ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958309 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention