BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22333668 · Received June 25, 2025

    Report

    Report Number
    2210968-2025-07455
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    August 17, 2024
    Report Date
    June 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: BMJ CASE REP. 2024 SEP 10;17(9):E261439. DOI: 10.1136/BCR-2024-261439. PMID: 39256174. HTTPS://DOI.ORG/10.1136/BCR-2024-261439.

    Description of Event or Problem · 0

    REDUCTION CHEILOPLASTY WITH LATERAL WEDGE EXCISIONS IN CHEILITIS GRANULOMATOSA. THIS ARTICLE PRESENTS THE CASE OF A WOMAN IN HER 50S PRESENTED WITH OEDEMA OF THE LOWER LIP. THE INTERMITTENT SWELLING BECAME CHRONIC OVER TIME. THE TENTATIVE DIAGNOSIS CHEILITIS GRANULOMATOSA WAS SUSPECTED FOLLOWING A BIOPSY SHOWING GRANULOMAS AND INFLAMMATION. A 4¿0 VICRYL (ETHICON) WAS USED TO SUTURED THE INTRAORAL WOUNDS. REPORTED COMPLICATIONS ARE : -PARTIAL WOUND DEHISCENCE AND SIGNS OF INFECTION WERE NOTED AT THE COMMISSURES (N=1) TREATMENT : ANTIBIOTICS WERE ADMINISTRATED, LEADING TO COMPLETE WOUND HEALING BY POSTOPERATIVE DAY 14. -A TINKLING SENSATION IN THE LIP STILL PERSISTED (N=1) TREATMENT : PATIENT CONFIRMED NORMAL SENSITIVITY AND MUSCLE FUNCTION. IN CONCLUSION, SURGERY IS CONSIDERED THE LAST RESORT WHEN THE SWELLING DOES NOT RESPOND TO MEDICAL TREATMENT AND THE CHRONIC INCREASED VOLUME AND DISFIGUREMENT LEAD TO SOCIAL STIGMATISATION AND SOMETIMES AFFECTED ORAL FUNCTION. MEDICAL TREATMENT CAN BE CUMBERSOME AND LONG LASTING, WHICH MEANS THAT PATIENTS OFTEN WAIT FOR YEARS BEFORE THEY ARE REFERRED FOR SURGERY. THERE IS NO EVIDENCE IN THE LITERATURE SUGGESTING THAT SURGERY SHOULD BE AVOIDED WHEN TREATING THIS CHRONIC CONDITION. EVEN THOUGH THE SURGICAL RESULTS ARE PROMISING, FURTHER FOLLOW-UP IS NEEDED REGARDING POSSIBLE RELAPSE. MAYBE SURGERY SHOULD BE CONSIDERED EARLIER AND MORE OFTEN AS IS CURRENTLY THE CASE. CONSIDERATION OF THE PATIENT¿S PERSPECTIVE MUST BE INCLUDED IN THIS DECISION. THIS WAS THE MOST IMPORTANT TAKE-HOME MESSAGE FROM OUR PATIENT¿S POINT OF VIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583159 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention