BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19039854 · Received April 4, 2024

    Report

    Report Number
    2210968-2024-03845
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    April 21, 2022
    Report Date
    April 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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: HTTPS://DOI.ORG/10.1093/ASJ/SJAC086

    Description of Event or Problem · 0

    TITLE: THE EFFECT OF A NOVEL PLATYSMA HAMMOCK FLAP DURING EXTENDED DEEP PLANE FACELIFT ON THE SIGNS OF AGING IN THE NECK THE AIM OF THE STUDY WAS TO ASSESS THE LONG-TERM IMPROVEMENT IN PLATYSMA BANDING (PB), SKIN LAXITY (SL), AND SUBMANDIBULAR GLAND VISIBILITY (SGV) WITH ADDITION OF APLATYSMAL HAMMOCK FLAP TO THE EXTENDED DEEP-PLANE FACELIFT AND ASSESS PATIENT SATISFACTION. THIS WAS A PROSPECTIVE STUDY OF 123 PATIENTS WHO UNDERWENT AN EXTENDED DEEP-PLANE RHYTIDECTOMY UTILIZING THE TECHNIQUE DEVELOPED BY THE SENIOR AUTHOR (A.A.J.) WITH THE INCORPORATION OF A PLATYSMA HAMMOCK FLAP BETWEEN FEBRUARY 1, 2017, AND JUNE 30, 2017. DURING THE PROCEDURE THE SUPRAHYOID PLATYSMA SEGMENT IS PLICATED AND FIXATED WITH INTERRUPTED 3-0 VICRYL SUTURES (ETHICON). REPORTED COMPLICATION ARE SEROMA, MINOR HEMATOMA, PLATYSMAL FIBROSIS, TEMPORARY FACIAL NERVE INJURY, SCARRING/KELOID, WOUND DEBRIDEMENT/INFECTION AND SUPERFICIAL EPIDERMOLYSIS. IN CONCLUSION, EXTENDED DEEP-PLANE FACELIFT WITH A PLATYSMAL HAMMOCK FLAP ACHIEVES LONG-TERM, SUSTAINED IMPROVEMENTS IN PB, SL, AND SGV; IS WELL-TOLERATED; AND RESULTS IN SUBSTANTIAL PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76613 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention