BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18787514 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-01948
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    December 21, 2021
    Report Date
    February 27, 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
    EG
    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. CITATION: AMERICAN JOURNAL OF OTOLARYNGOLOGY¿HEAD AND NECK MEDICINE AND SURGERY (2022); 43:103334. HTTPS://DOI.ORG/10.1016/J.AMJOTO.2021.103334

    Description of Event or Problem · 0

    TITLE: A COMPARATIVE STUDY OF LASER POSTERIOR CORDOTOMY AND COMBINED LASER POSTERIOR CORDOTOMY WITH SUTURE LATERALIZATION IN BILATERAL VOCAL CORDS ABDUCTOR PARALYSIS THE AIM OF THIS PROSPECTIVE RANDOMIZED STUDY IS TO COMPARE THE EFFECT OF BOTH SURGICAL TECHNIQUES (LASER POSTERIOR CORDOTOMY AND COMBINED LASER POSTERIOR CORDOTOMY WITH SUTURE LATERALIZATION) ON RESPIRATION AND QUALITY OF VOICE. BETWEEN JANUARY 2018 AND JANUARY 2021, A TOTAL OF 40 PATIENTS (22 MALE AND 18 FEMALE; MEAN AGE WAS 45 ± 10 YEARS) WITH TRUE BILATERAL VOCAL FOLD ABDUCTOR PARALYSIS WERE INCLUDED IN THE STUDY. THE PATIENTS UNDER THE STUDY WERE DIVIDED INTO 2 EQUAL GROUPS RANDOMLY, GROUP (A) INCLUDING 20 PATIENTS WHO UNDERWENT LASER POSTERIOR CORDOTOMY AND ANOTHER GROUP (B) INCLUDING 20 PATIENTS WHO UNDERWENT COMBINED LASER POSTERIOR CORDOTOMY WITH SUTURE LATERALIZATION. IN GROUP B THE ANTERIOR EDGE OF THE VAPORIZED VOCAL FOLD WAS LATERALIZED BY ONE PROLENE SUTURE USING LICHTENBERGER ENDOEXTRALARYNGEAL NEEDLE CARRIER. REPORTED COMPLICATIONS INCLUDE INADEQUATE RESPIRATION POST 1 YEAR (N=2), ASPIRATION POST 2 WEEKS (N=8) AND POST 4 WEEKS (N=1), GRANULOMA FORMATION (N=1), LARYNGEAL EDEMA WITHIN 1 WEEK (N=8), COMPLICATION OF GA (N=1), AND LOCAL WOUND COMPLICATIONS/HEMATOMA DUE TO INFECTED SUTURE (N=3). IN CONCLUSION, COMBINED LASER POSTERIOR CORDOTOMY WITH SUTURE LATERALIZATION IN BILATERAL VOCAL FOLDS ABDUCTOR PARALYSIS SHOWED FEWER COMPLICATIONS AND BETTER MAXIMUM PHONATION TIME AND A COMPARABLE EFFECT TO LASER CORDOTOMY REGARDING RESPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111010 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention