BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICGEL PADS

    MDR report key: 8501332 · Received April 10, 2019

    Report

    Report Number
    1018233-2019-01830
    Event Type
    Injury
    Date Received
    April 10, 2019
    Report Date
    April 10, 2019
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K142702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, BARD/BD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARCTIC SUN GEL PADS WERE REMOVED, AS PER POLICY, TO CHECK SKIN INTEGRITY. SKIN TEARING WAS OBSERVED AS THE PADS WERE REMOVED. THERE WERE MULTIPLE SKIN TEARS TO THE PATIENT'S ABDOMEN, TRUNK AND LEFT THIGH. THE PATIENT'S SKIN WAS FRAGILE AND THE PATIENT WAS IN MULTIPLE ORGAN FAILURE (MOF). THE DEVICE WAS IMMEDIATELY REMOVED FROM SERVICE AND PUT IN QUARANTINE FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARCTIC SUN GEL PADS WERE REMOVED, AS PER POLICY, TO CHECK SKIN INTEGRITY. SKIN TEARING WAS OBSERVED AS THE PADS WERE REMOVED. THERE WERE MULTIPLE SKIN TEARS TO THE PATIENT'S ABDOMEN, TRUNK AND LEFT THIGH. THE PATIENT'S SKIN WAS FRAGILE AND THE PATIENT WAS IN MULTIPLE ORGAN FAILURE (MOF). THE DEVICE WAS IMMEDIATELY REMOVED FROM SERVICE AND PUT IN QUARANTINE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292591 ARTICGEL PADS ARCTIC SUN GEL PADS DWJ MEDIVANCE, INC. ¿ 1725056 NGCY1740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other