BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 22989994 · Received September 8, 2025

    Report

    Report Number
    3003442380-2025-13444
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 30, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K991759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010289, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 26-AUG-2025 AGAINST FINAL REPORTING DECISION EQUAL SERIOUS INJURY AND DEATH, LOT NUMBER CRITERIA EQUAL LOT NUMBER 6010289. THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010289 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 16-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT A NON-CONFORMANCE (NC) 2081027 WAS OPENED DURING STERILIZATION PROCESS. THE VERICYCLE REPORT WERE VERIFIED BY STERIGENICS GRAND PRAIRIE AS PASS, THEY DID NOT INFORM THIS ISSUE AND DOES NOT SEND NO CONFORMITY OR DEFICIENCY REPORT. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, ONE NON-CONFORMANCE (NC) RAISED DURING STERILIZATION PROCESS NO RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 210 MG/DL AND PATIENT WAS TREATED WITH INSULIN VIA SYRINGE. THE LENGTH OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495885 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6010289 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R