BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN UNIVERSAL HEAD POSITIONER (UHP)

    MDR report key: 1966945 · Received January 13, 2011

    Report

    Report Number
    1221538-2011-00003
    Event Type
    Other
    Date Received
    January 13, 2011
    Report Date
    December 16, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER DECLINED ALLENS' OFFER TO HAVE THE UNIVERSAL HEAD POSITIONER RETURNED FOR EVALUATION. ROOT CAUSE FOR THE POST-OPERATIVE POSITIONING ISSUE WAS NOT DETERMINED, THE REPORTER SAID. THE HOSPITAL CONTINUES TO USE THE UHP AND THERE HAVE BEEN NO FURTHER ISSUES TO REPORT, SHE SAID. THE SALES REP IS WORKING WITH THE STAFF.

    Description of Event or Problem · 1

    AN ALLEN MEDICAL REP WAS CONTACTED ON (B)(6) 2010, TO REPORT POST-OPERATIVE NUMBNESS IN THE ARMS OF A PATIENT FOLLOWING A POSITIONING CASE IN WHICH THE UNIVERSAL HEAD POSITIONER (UHP) WAS USED. THERE WAS NO INCIDENT TO REPORT DURING THE CASE. POST-OPERATIVELY, WHEN THE ANESTHESIA WORE OFF, THE PATIENT REPORTED NUMBNESS IN THEIR ARMS TO THE STAFF. THE PATIENT IS BEING TREATED BY THE HOSPITAL FOR THE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN UNIVERSAL HEAD POSITIONER (UHP) HEAD POSITIONER FWZ ALLEN MEDICAL SYSTEMS A-90022-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other