BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HAMMR

    MDR report key: 20647729 · Received November 9, 2024

    Report

    Report Number
    3010849408-2024-00001
    Event Type
    Malfunction
    Date Received
    November 9, 2024
    Date of Event
    August 23, 2024
    Report Date
    August 30, 2024
    Manufacturer
    CELESTICA
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CELESTICA IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING OBLIGATIONS UNDER 21 CFR, PART 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY CELESTICA, WHICH CELESTICA MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. CELESTICA HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, CELESTICA, OR ITS EMPLOYEES THAT THE DEVICE, CELESTICA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. DURING THE EVALUATION IT WAS DETERMINED A POTENTIAL MISUSE DURING OR AFTER THE AUTOCLAVE STERILIZATION STEP OCCURRED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE OR PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPACTOR DEVICE WAS LEAKING WATER. THIS EVENT OCCURRED DURING SURGERY SO THE PATIENT WAS INVOLVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT DID NOT DEVELOP AN INFECTION AFTER THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540483 HAMMR HAMMR GEY CELESTICA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female