BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 14167979 · Received April 21, 2022

    Report

    Report Number
    2210968-2022-02844
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    August 20, 2021
    Report Date
    April 21, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION CITE: J. CLIN. MED. 2021, 10, 3713. HTTPS://DOI.ORG/10.3390/JCM10163713.

    Description of Event or Problem · 0

    TITLE: OTOPLASTY THROUGH VENTRAL SKIN INCISION AND SHAPING OF THE ANTIHELIX BY ABRASION¿A RETROSPECTIVE STUDY. THIS RETROSPECTIVE STUDY ANALYSES 937 PATIENTS FROM OUR DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY AT AGAPLESION MARKUS HOSPITAL IN FRANKFURT, GERMANY, WHO UNDERWENT AESTHETIC OTOPLASTY OVER A 30-YEAR PERIOD, FROM 1985 TO 2014. DATA COLLECTION AND ANALYSIS WAS PERFORMED RETROSPECTIVELY FROM 2015 TO 2016. PATIENT FOLLOW-UP RECORDS RANGED FROM 3 TO 24 MONTHS WITH A MEDIAN FOLLOW-UP OF 12 MONTHS. FIXATION OF THE FOLDED ANTIHELIX WITH TWO OR THREE MONOFILAMENT NON-ABSORBABLE 4¿0 ETHICON ETHILON POLYAMID 6 (ONE JOHNSON & JOHNSON PLAZA, NEW BRUNSWICK, NJ, USA) WHERE THE KNOT IS FACING TOWARDS THE CONCHA. REPORTED COMPLICATIONS INCLUDED HEMATOMA, RECURRENCE OF EAR PROTRUSION, OCCURRENCE OF SUTURE GRANULOMAS, IMPAIRED WOUND HEALING (INCLUDING MINOR WOUND MARGIN NECROSIS OR DEHISCENCE), HYPERTROPHIC SCARRING, AND INFECTION. IN GENERAL, HYPERTROPHIC SCARS AND KELOIDS ON EARS OCCUR ONLY AFTER LOCAL INFECTIONS. THEREFORE, IT IS NO WONDER THAT THERE IS ONLY ONE HYPERTROPHIC SCAR IN OUR SERIES OF MAINLY CHILDREN, AND ALMOST ALL SCARS ALONG THE INNER HELIX BECAME INVISIBLE OVER THE FOLLOWING MONTHS. THEREFORE, WE CAN RECOMMEND THIS TECHNIQUE TO BE EASY, SAFE, AND AESTHETICALLY EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921563 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention