BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24078545 · Received January 15, 2026

    Report

    Report Number
    2210968-2026-00537
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    January 1, 2024
    Report Date
    January 15, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THERE ARE NO CONTACT DETAILS GIVEN WITHIN THIS EVENT AND THEREFORE NO FOLLOW UP WILL BE PERFORMED. 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: INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CLINICAL RESEARCH 2024; 16(4); 243-249

    Description of Event or Problem · 0

    PROSPECTIVE STUDY TO EVALUATE THE FUNCTIONAL OUTCOME IN PATIENTS WITH DISTAL TIBIA FRACTURES UNDERGOING LOCKING COMPRESSION PLATE FIXATION USING MINIMAL INVASIVE ¿MIPPO¿ TECHNIQUE. THE AIM OF THE STUDY THE FUNCTIONAL OUTCOME OF DISTAL TIBIA FRACTURES IN PATIENTS TREATED BY MINIMAL INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS (MIPPO) TECHNIQUE WITH DISTAL TIBIA LOCKING COMPRESSION PLATE. THIS STUDY HAD A PROSPECTIVE CLINICAL STUDY DESIGN CONDUCTED AT GOVT. R. D. B. P. JAIPURIA HOSPITAL ATTACHED WITH RUHS COLLEGE OF MEDICAL SCIENCES, JAIPUR, RAJASTHAN. TOTAL OF 30 PATIENTS WITH CLOSED, OPEN FRACTURE TYPE 1 (GUSTILO AND ANDERSON CLASSIFICATION) FRACTURE OF DISTAL TIBIA WITH OR WITHOUT INTRA ARTICULAR EXTENSION WERE INCLUDED IN THE STUDY. WOUND CLOSURE WAS PERFORMED BY USING SUBCUTANEOUS VICRYL AND ETHILON 2-0 SKIN SUTURE TO CLOSE THE INCISION SITE. REPORTED COMPLICATIONS INCLUDE: VICRYL (ETHICON) ETHILON (ETHICON) INFECTION (N=3) TREATMENT: NOT REPORTED IN CONCLUSION, THE PRESENT STUDY CONCLUDES THAT MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPPO) USING LCP IS A SAFER MODALITY FOR TREATING DISTAL TIBIAL FRACTURES WITHOUT SIGNIFICANT INTRA-ARTICULAR COMMINUTION BECAUSE IT PROMOTES RAPID FUNCTIONAL RECOVERY, GOOD FRACTURE HEALING, AND PREVENTS SERIOUS SKIN PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139927 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other