BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3041409 · Received April 8, 2013

    Report

    Report Number
    0001056128-2013-00033
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLF
    PMA / PMN Number
    K042316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. VERIFICATION OF THE INCOMING INSPECTION DOCUMENTS CONFIRMED THAT TAPES USED DURING THE MANUFACTURING OF THE RETURNED DEVICE MET MATERIAL SPECIFICATIONS AND DRAWING REQUIREMENTS AND WERE INSPECTED AND ACCEPTED BY QUALITY CONTROL PRIOR TO RELEASE TO PRODUCTION. A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. ALL REPROCESSED PULSE OXIMETER SENSORS ARE SUBJECTED TO 100% TESTING PRIOR TO RELEASE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE PULSE OXIMETER "STUCK TO PATIENT'S FINGER, SKIN PEELED OFF." THIS PRODUCED A BLISTER THAT BLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143447 NA NLF NLF STRYKER SUSTAINABILITY SOLUTIONS LAKELAND MAX-N 2350589

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention