BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINSTREL (INCL. MINERVA)

    MDR report key: 2111000 · Received April 7, 2011

    Report

    Report Number
    3004468271-2011-00018
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART WAS REPORTED TO HAVE BEEN SENT OUT TO THE MANUFACTURER ON (B)(6) 2011. FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE TRANSFER OF THE PATIENT, THE ARM OF THE DEVICE COMPLETELY CRACKED, CAUSING THE PATIENT TO FALL. THE FACILITY DID NOT RELEASE ANY OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINSTREL (INCL. MINERVA) PASSIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other