BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAL PRO STIRRUPS

    MDR report key: 2105335 · Received May 18, 2011

    Report

    Report Number
    1221538-2011-00009
    Event Type
    Other
    Date Received
    May 18, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAL PRO STIRRUP WAS RETURNED WITH NO FUNCTIONAL OR SAFETY ISSUES OF ANY KIND FOUND DURING EVALUATION. THESE RESULTS WERE SHARED WITH THE REPORTER. THE STAFF SAID THE POSITIONING INJURY RESULTED FROM A LENGTHY CASE AND RESOLVED COMPLETELY WITH TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A NURSE FROM MEMORIAL SLOAN KETTERING CONTACTED ALLEN MEDICAL TO REQUEST A PAL PRO STIRRUP BE EVALUATED FOLLOWING AN UNSPECIFIED POSITIONING INJURY SUSTAINED BY A PATIENT. THE CONDITION, DESCRIBED ONLY AS A TEMPORARY, POST-OPERATIVE "NEUROVASCULAR" ISSUE, RESOLVED WITH TREATMENT PRIOR TO THE DISCHARGE OF THE PATIENT FROM THE HOSPITAL. THERE WAS NO INCIDENT OR IMPACT TO THE CASE, THE REPORTER SAID, AND NO PERMANENT INJURIES OR DISABILITIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAL PRO STIRRUPS PAL PRO STIRRUPS FWZ ALLEN MEDICAL SYSTEMS A-10051-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other