BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEFLON PLEDGETS UNKNOWN PRODUCT

    MDR report key: 21011323 · Received December 24, 2024

    Report

    Report Number
    2210968-2024-13961
    Event Type
    Injury
    Date Received
    December 24, 2024
    Date of Event
    April 2, 2024
    Report Date
    December 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    DXZ
    PMA / PMN Number
    K811872
    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. 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 KOREAN NEUROSURG SOC 2024; 67 (6) : 646-653, HTTPS://DOI.ORG/10.3340/JKNS.2024.0003.

    Description of Event or Problem · 0

    TITLE: PRELIMINARY REPORT OF FULLY ENDOSCOPIC MICROVASCULAR DECOMPRESSION. THE AIM OF THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS TO DESCRIBE THE SAFETY AND EFFICACY OF THE FULLY ENDOSCOPIC MICROVASCULAR DECOMPRESSION (E-MVD) TECHNIQUE WITHOUT ANY ASSISTANCE OF THE MICROSCOPE. A TOTAL OF 25 PATIENTS [9 MALE AND 16 FEMALE; MEDIAN AGE WAS 55 YEARS (RANGE, 35¿72)] DIAGNOSED WITH HEMIFACIAL SPASM (HFS) BETWEEN SEPTEMBER 2019 AND JULY 2023. ALL SURGERIES WERE PERFORMED BY A SINGLE NEUROSURGEON USING THE FULLY E-MVD TECHNIQUE WITHOUT ANY ASSISTANCE OF A MICROSCOPE. WHEN THE OFFENDING VESSEL WAS IDENTIFIED, TEFLON (TFE POLYMER PLEDGET; ETHICON, INC., RARITAN, NJ, USA) WAS INSERTED USING FORCEPS AND SECURED WITH FIBRIN GLUE. REPORTED COMPLICATIONS INCLUDE POST-OPERATIVE HEARING IMPAIRMENT (N=1), SYMPTOM RECURRENCE (N=2), DELAYED FACIAL PALSY (N=8), AND IN A 64-YEAR-OLD MAN (N=1), LATERAL SPREAD RESPONSE RECURRED WHEN THE RETRACTED VA RETURNED TO ITS ORIGINAL POSITION. IN CONCLUSION, FULLY E-MVD DEMONSTRATED SIMILAR CLINICAL OUTCOMES TO MICROSCOPIC MVD. IT OFFERED A SIMILAR COMPLICATION RATE, SHORTER OPERATION TIME, AND A PANORAMIC VIEW WITH A SMALLER CRANIECTOMY SIZE. ALTHOUGH THERE IS A LEARNING CURVE ASSOCIATED WITH FULLY E-MVD, IT PRESENTS A VIABLE ALTERNATIVE IN THE ENDOSCOPIC ERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994988 TEFLON PLEDGETS UNKNOWN PRODUCT PATCH, PLEDGET AND INTRACARDIAC DXZ ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention