BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22189131 · Received June 11, 2025

    Report

    Report Number
    2210968-2025-06663
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    March 26, 2024
    Report Date
    June 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: EUR ARCH OTORHINOLARYNGOL. 2024 JUN;281(6):3283-3287. DOI: 10.1007/S00405-024-08503-5. EPUB 2024 MAR 26. PMID: 38530458. HTTPS://DOI.ORG/10.1007/S00405-024-08503-5.

    Description of Event or Problem · 0

    EXTERNAL AUDITORY CANAL RECONSTRUCTION USING A NOVEL MASTOIDOPLASTY TECHNIQUE DURING CANAL WALL DOWN MASTOIDECTOMY: HOW I DO IT. THE AIM OF THIS STUDY IS TO PRESENT THE AUTHORS' MASTOIDOPLASTY TECHNIQUE. BETWEEN 2014 AND 2022, A TOTAL OF 43 EARS IN 42 PATIENTS WHO UNDERWENT MASTOIDOPLASTY PROCEDURE WERE INCLUDED IN THE STUDY. THE INFERIORLY BASED PERIOSTEAL FLAP (IPF) IS SUTURED WITH 2¿3 INTERRUPTED VICRYL SUTURES TO THE POSTAURICULAR SOFT TISSUES TO CREATE A NEW POSTERIOR EAR CANAL. TISSUE AND SUBCUTANEOUS CLOSURE IS WITH VICRYL 3-0. REPORTED COMPLICATIONS INCLUDE (N=2) HAD A DEGREE OF NARROWING OF THE NEO-EXTERNAL AUDITORY CANAL (EAC) TREATMENT: NO FURTHER PROCEDURAL INTERVENTION REQUIRED (N=1) TYMPANIC MEMBRANE PERFORATION. TREATMENT: WHICH WAS SUCCESSFULLY REPAIRED WITH OUTPATIENT PAPER PATCH APPLICATION (N=1) TYMPANIC MEMBRANE RETRACTION. TREATMENT: WHICH IS BEING CLINICALLY MONITORED ON ROUTINE FOLLOW UP. (N=2) CHOLESTEATOMA RECURRENCE. TREATMENT: NOT REPORTED. (N=2) POSTOPERATIVE INFECTION TREATMENT: NOT REPORTED (N=1) PULSATILE TINNITUS. TREATMENT: NOT REPORTED. IN CONCLUSION, THE CONCEPT OF OUR MASTOIDOPLASTY POTENTIALLY PROVIDES A VERY USEFUL ALTERNATIVE IN RECREATING A NEAR NORMAL EAR CANAL ANATOMY AVOIDING CAVITY PROBLEMS AS WELL AS FACILITATING HEARING AID FITTING WITH CANAL TYPE HEARING AIDS AFTER CANAL WALL DOWN MASTOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92909 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other