BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3130986 · Received April 22, 2013

    Report

    Report Number
    3005225477-2013-00003
    Event Type
    Other
    Date Received
    April 22, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    FSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE DEFECTIVE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER. THE ABDOMINAL BINDER IS LATEX FREE AND HAS HAD NO NEW MATERIAL CHANGES. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THEY ARE HAVING SEVERAL PATIENTS GET BAD REACTIONS TO THE ABDOMINAL BINDER. PATIENTS HAVE BROKE OUT IN RED BLOTCHES AND THERE WAS ONE PATIENT THAT GOT HIVES. THEY HAD TO GIVE THIS PATIENT STEROID CREAM AND BENADRYL. IT COULD BE THE BINDER OR THE SKIN PREP CAUSING THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173258 DEROYAL FSD DEROYAL GUATEMALA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other