BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 15798419 · Received November 15, 2022

    Report

    Report Number
    2210968-2022-09453
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    May 6, 2021
    Report Date
    November 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: AESTHETIC SURGERY JOURNAL 2022; 42(1):16¿27. HTTPS://DOI.ORG/10.1093/ASJ/SJAB212.

    Description of Event or Problem · 0

    TITLE: BALANCED CANTILEVER GRAFT FOR SUPPORTING THE CARTILAGINOUS SIDE WALL OF NOSE. THE AIM OF THIS STUDY WAS TO ASSESS THE BALANCED CANTILEVER GRAFT (BCLG) AS A TECHNIQUE TO SUPPORT THE LATERAL NASAL WALL. BETWEEN JANUARY 2018 AND DECEMBER 2019, A TOTAL OF 60 PATIENTS (34 MALE AND 26 FEMALE; MEAN AGE OF 31 YEARS [RANGE 18 TO 57 YEARS]) WHO UNDERWENT PRIMARY OPEN SEPTORHINOPLASTY WITH BALANCED CANTILEVER GRAFT WERE INCLUDED. 5.0 VICRYL RAPIDE WAS USED TO FIXED ONE END OF THE BCLG IN A SUBMUCOSAL POCKET FOR EASE OF MANIPULATING THE OTHER END INTO THE OTHER POCKET. WHEN A BCLG WAS BEING USED TO SUPPORT THE LATERAL CRURA, ITS EDGES WERE SECURED IN SUBMUCOSAL POCKETS UNDER BOTH LATERAL CRURA WITH 5-0 VICRYL RAPIDE. FOLLOW-UP PERIOD VARIED FROM 6 TO 24 MONTHS (MEAN, 17 MONTHS). REPORTED COMPLICATIONS INCLUDE RIGHT-SIDED NASAL OBSTRUCTION AND SUPRATIP DEPRESSION (N=1) AND PERSISTENT RIGHT-SIDED NASAL OBSTRUCTION (N=1). IN CONCLUSION, BCLGS SUPPORT THE WEAKENED PART OF LATERAL NASAL WALL BY THEIR ELASTANCE. MINIMAL CARTILAGE IS REQUIRED AND THE GRAFT CAN BE ALTERED TO SUPPORT VARIOUS PARTS OF THE LATERAL NASAL WALL. THIS GRAFT DOES NOT CAUSE AN AESTHETIC DEFICIENCY WHILST PROVIDING ADEQUATE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757736 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention