BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2188078 · Received August 2, 2011

    Report

    Report Number
    1056128-2011-00070
    Event Type
    Injury
    Date Received
    August 2, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLF
    PMA / PMN Number
    K081238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. THE PACKAGING WAS NOT SAVED EITHER. THE PROCEDURE DATE AND DEVICE INFORMATION ARE ALL UNKNOWN. THE COMPLAINT DEVICE IS NOT APPROPRIATE FOR NEONATAL OR INFANT APPLICATION. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. A POTENTIAL CAUSE IS USING AN ADULT PULSE OXIMETER ON AN INFANT, APPLICATION AND REMOVAL TECHNIQUE OF THE DEVICE, AND UNKNOWN PATIENT CLINICAL CONDITIONS. ALL REPROCESSED PULSE OXIMETER SENSORS ARE SUBJECTED TO 100% TESTING PRIOR TO RELEASE. THIS IS THE FIRST COMPLAINT FOR THIS DEVICE RELATED TO TAPE ADHESION ISSUES THAT STRYKER SUSTAINABILITY SOLUTIONS HAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TAPE ON THE PULSE OXIMETER TORE THE SKIN ON THE TOP OF THE FOOT OF A 23 WEEK GESTATION BABY. A LOOSE GAUZE DRESSING WAS USED TO TREAT THE SKIN TARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLF NLF STRYKER SUSTAINABILITY SOLUTIONS 2320 UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other