BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 17430783 · Received July 31, 2023

    Report

    Report Number
    2210968-2023-05506
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    July 20, 2022
    Report Date
    July 31, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 472 G/M. 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. CITATION: THE JOURNAL OF CRANIOFACIAL SURGERY 2023;34: 870¿874. HTTPS://DOI.ORG/10.1097/SCS.0000000000008967.

    Description of Event or Problem · 0

    TITLE: NASAL TIP AND ALAR GROOVE PLASTY THROUGH EXTERNAL NASAL CUTTING IN ASIANS: A CLINICAL STUDY. THIS STUDY AIMS TO INTRODUCE A NEW PROCEDURE OF NASAL TIP AND ALAR GROOVE PLASTY THROUGH EXTERNAL NASAL CUTTING IN ASIANS. NASAL TIP HYPERTROPHY IS COMMON IN ASIANS, AND ITS RESHAPING IS VERY CRITICAL IN RHINOPLASTY. FOR PATIENTS WHO REFUSE ANY IMPLANT PLACED IN THE NOSE, THERE ARE LIMITED OPTIONS FOR TIP RESHAPING. A TOTAL OF 20 PATIENTS WHO HAD HYPERTROPHIC NASAL TIP AND REFUSED TO HAVE ANY IMPLANTS WERE INCLUDED IN THIS STUDY. THEY WERE PERFORMED THIS PROCEDURE OF NASAL TIP AND ALAR GROOVE PLASTY THROUGH EXTERNAL NASAL CUTTING. WE INCISED THE ENTIRE NASAL TISSUE ALONG THE DESIGN LINE FROM THE EPIDERMIS TO THE MUCOSAL LAYER. THE MARKED TISSUE WAS FULLY FREED AND COMPLETELY EXCISED. DURING THIS PROCESS, WE USUALLY RESECT THE TISSUE ALONG THE EDGES OF THE CARTILAGO ALARIS MAJOR, AND TRY TO PRESERVE THE INTACT CARTILAGO ALARIS MAJOR. AFTER EXCISION OF THE TISSUE, WE FIRST SUTURED THE MUCOSAL LAYER WITH 5-0 VICRYL PLUS ABSORBABLE SUTURES. AS TO THE MUCOSAL LAYER NEAR THE CEPHALIC END, WE SUTURED THROUGH THE INCISION ON THE OUTSIDE OF THE NOSE, AND THE MUCOSA NEAR THE NASAL MARGIN, WE COULD SUTURE THROUGH THE NASAL CAVITY. AFTER THE MUCOSAL LAYER WAS SUTURED, WE PERFORMED TENSION-REDUCING SUTURE ON THE SUBCUTANEOUS TISSUE LAYER WITH 5-0 VICRYL PLUS ABSORBABLE SUTURES. REPORTED COMPLICATION INCLUDED SIGNIFICANT SCARRING OF THE NASAL WOUND IN 1 PATIENT. THIS PROCEDURE OF NASAL TIP AND ALAR GROOVE PLASTY THROUGH EXTERNAL NASAL CUTTING COULD BE AN ALTERNATIVE FOR MAKING THE TIP OF THE NOSE MORE REFINED. IF THE SURGICAL SITE IS WELL SUTURED, THE SCARRING IN MOST PATIENTS IS NOT OBVIOUS. HOWEVER, IN SOME ASIANS, IT MAY BE RELATIVELY OBVIOUS, WHICH NEEDS TO BE FULLY COMMUNICATED WITH THE PATIENT BEFORE THE OPERATION. IF THE PATIENT CANNOT ACCEPT THE SCAR BEFORE THE OPERATION, THE SURGEONS SHOULD NOT TRY TO DO THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660414 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention