BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALSTED-MOSQUITO FCPSDELSTR1X2125MM

    MDR report key: 4120804 · Received July 28, 2014

    Report

    Report Number
    2916714-2014-00583
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    April 24, 2014
    Report Date
    July 28, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVALUATION: THE ISSUE HAS BEEN CAUSED BY A MFG ERROR, WHICH WAS NOT DETECTED IN FINAL INSPECTION. ALL RESPONSIBLE PERSONNEL HAVE BEEN INFORMED REGARDING THIS ISSUE IN ORDER TO ENSURE IT IS AVOIDED IN THE FUTURE. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). COMPLAINT: THE MOUSE TOOTH OF THE JAW WAS MISSING. WHEN THE SURGEON TRIED TO USE THIS PRODUCT IN SURGERY, E FOUND THAT THE MOUSE TOOTH OF THE JAW WAS MISSING. THE FRAGMENT HAS NOT BEEN FOUND YET. PRIMARY SURGERY: (B)(6) 2014. REVISION SURGERY: NONE. PT DATA: UNK. FURTHER DETAIL: NONE. INVOLVED COMPONENT: NONE. REASON FOR VIGILANCE SUSPICIOUS: FRAGMENT HAS NOT BEEN FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439890 HALSTED-MOSQUITO FCPSDELSTR1X2125MM VASCULAR CLAMP HRQ AESCULAP AG & CO. KG BH120R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other