BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18684302 · Received February 12, 2024

    Report

    Report Number
    2210968-2024-01231
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    March 15, 2019
    Report Date
    February 12, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. RELATED EVENTS CAPTURED VIA 2210968-2024-01230. CITATION: AESTHETIC SURGERY JOURNAL 2019, VOL 39(12) 1284¿1294/. HTTPS://DOI.ORG/10.1093/ASJ/SJZ077.

    Description of Event or Problem · 0

    TITLE: "DYNAMIC CANTHOPEXY¿ DRILL HOLE CANTHAL REPOSITIONING. THE OBJECTIVE OF THIS STUDY IS TO DEMONSTRATE THE DIFFERENCES AND THE EFFICACY OF THE DYNAMIC CANTHOPLASTY. BETWEEN JANUARY 2005 TO MARCH 2015, A TOTAL OF 30 PATIENTS TREATED WITH A ¿DYNAMIC CANTHOPEXY". THE 18 PATIENTS WHO PRESENTED WITH AN ANTI-MONGOLOID PALPEBRAL SLANT WERE AGED A MEAN OF 29 YEARS (RANGE, 18-38 YEARS). THE 12 PATIENTS WITH TYPICAL EYE SHAPE WHO DESIRED AN ASIAN EYE APPEARANCE HAD A MEAN AGE OF 31 YEARS (RANGE, 20-35 YEARS). IN THE CURRENT STUDY, ALL PATIENTS RECEIVED THOROUGH PREOPERATIVE GUIDANCE ABOUT WHAT TO EXPECT AFTER SURGERY, BUT 1 PATIENT (3.3%) WAS UNCOMFORTABLE WITH HER POSTOPERATIVE APPEARANCE AND CHOSE TO UNDERGO REVISIONAL SURGERY TO REMOVE THE SUSPENSION SUTURES. IN THE PRESENT STUDY, EXCESSIVE LOWER-LID TENSION OCCURRED IN 4 PATIENTS (ABOUT 15%) AND WAS ASSOCIATED WITH IMPAIRED EYE CLOSURE. ONE PATIENT (3.3%) EXPERIENCED ASYMMETRY DUE TO EARLY UNILATERAL DETACHMENT OF THE SUSPENDING SUTURE AND REQUIRED REVISIONAL SURGERY AT 1 YEAR. IN THIS STUDY, 3 OF THE 30 PATIENTS (10%) EXPERIENCED CHEMOSIS, INCLUDING THOSE WITH DOWNSLANTING PALPEBRAL FISSURE FEATURES PREOPERATIVELY AND THOSE WHO DESIRED ENHANCED UPSLANTING OF TYPICALLY SHAPED EYES. IN THESE PATIENTS, CHEMOSIS PERSISTED FOR APPROXIMATELY 2 TO 3 WEEKS AFTER SURGERY AND WAS ACCOMPANIED BY A BURNING SENSATION, INCREASED MUCUS DISCHARGE, AND TRANSIENT, MILD BLURRED VISION. A 5-0 NYLON OR POLYPROPYLENE SUTURE (PROLENE, ETHICON, SOMERVILLE, NJ) WAS PASSED THROUGH THE LOWER OF THE 2 HOLES FROM OUTSIDE TO INSIDE. SPECIFICALLY, AN ORBICULARIS FLAP, TAKEN FROM THE LOWER EYELID, WAS FIXED TO THE DRILL HOLES, THE PERIOSTEUM, OR BOTH ON THE EXTERNAL SIDE OF THE SUPEROLATERAL ORBITAL RIM WITH A 4-0 POLYGLACTIN 910 SUTURE (VICRYL, ETHICON). REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE APPEARANCE UNCOMFORTABLE (N=1), EXCESSIVE LOWER-LID TENSION ASSOCIATED WITH IMPAIRED EYE CLOSURE (N=4), ASYMMETRY DUE TO EARLY UNILATERAL DETACHMENT OF THE SUSPENDING SUTURE (N=1), AND CHEMOSIS ACCOMPANIED BY A BURNING SENSATION, INCREASED MUCUS DISCHARGE, AND TRANSIENT, MILD BLURRED VISION (N=3). IN CONCLUSION, DYNAMIC CANTHOPEXY CAN PROVIDE STABLE CORRECTION OF ANTI-MONGOLIAN SLANT. IT CAN ALSO BE EFFECTIVELY EMPLOYED TO OBTAIN PERMANENT SLANT EYES WHEN REQUIRED BY PURELY COSMETIC PATIENTS. IF PRECISELY CARRIED OUT, THIS TECHNIQUE CAN YIELD VERY REWARDING OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464327 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention