BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN

    MDR report key: 11251234 · Received January 29, 2021

    Report

    Report Number
    3000719969-2021-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    December 31, 2020
    Report Date
    January 14, 2021
    Manufacturer
    OLSEN MEDICAL, LLC
    Product Code
    HOY
    UDI-DI
    00841785107702
    PMA / PMN Number
    K852404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A TOTAL OF (B)(4) BOXES OF 12 (42,756 UNITS) SOLD OF ALL LOTS SINCE 2012 WITH NO ADDITIONAL COMPLAINTS RECORDED. THE PART OF THE PRODUCT THAT TOUCHES THE SKIN AROUND THE EYES IS AN ADHESIVE. THE (B)(4) STATES TO MAKE SURE THAT THE PATIENT DOES NOT HAVE AN ALLERGY TO EKG ADHESIVE. IT IS MOST LIKELY THAT THE CUSTOMER HAD AN ALLERGIC REACTION TO THE ADHESIVE ON THE DEVICE. THE (B)(4) WAS PROVIDED TO THE CUSTOMER AND THE CASE IS BEING CLOSED ON THE CUSTOMER'S END WITH NO FURTHER INVESTIGATION NECESSARY. THIS CAN BE SEEN AT THE INITIAL AND FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SOFT TISSUE INJURY AFTER REMOVAL OF THE EYE SHIELD. THERE WAS NO LONG TERN AFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145589 OLSEN EYE SHIELD HOY OLSEN MEDICAL, LLC 607000 117891 00841785107702

    Patients

    Seq Age Sex Outcome Treatment
    1