BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 17153206 · Received June 19, 2023

    Report

    Report Number
    2210968-2023-04406
    Event Type
    Injury
    Date Received
    June 19, 2023
    Report Date
    June 19, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. THIS REPORT IS RELATED TO A CLINICAL EVALUATION REPORT; 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS UNDERGOING EVALUATION OF PERFORMANCE AND SAFETY OUTCOMES OF VICRYL SUTURE. PATIENT IMPACT HAS BEEN IDENTIFIED AS THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: 5,738 PATIENTS WITH BLEEDING DURING THE INDEX ADMISSION, DEFINED AS THE PRESENCE OF AN ICD-9/10-CM DIAGNOSIS CODE FOR POSTPROCEDURAL BLEEDING (SEE APPENDIX 1: DIAGNOSIS CODES FOR BLEEDING) DURING THE INDEX ADMISSION WHERE A STUDY DEVICE WAS USED. 6,944 PATIENTS WITH WOUND DISRUPTION DURING THE INDEX ADMISSION, DEFINED AS THE PRESENCE OF AN ICD-9/10-CM DIAGNOSIS CODE FOR WOUND DISRUPTION (SEE APPENDIX 2: DIAGNOSIS CODES FOR WOUND DISRUPTION) DURING THE INDEX ADMISSION WHERE A STUDY DEVICE WAS USED. 3,371 PATIENTS WITH SURGICAL SITE INFECTION DURING THE INDEX ADMISSION, DEFINED AS THE PRESENCE OF AN ICD-9/10-CM DIAGNOSIS CODE FOR SURGICAL SITE INFECTION (SEE APPENDIX 3: DIAGNOSIS CODES FOR SURGICAL SITE INFECTION) DURING THE INDEX ADMISSION WHERE A STUDY DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814043 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention