BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA DEEPSEE TRANSDUCER

    MDR report key: 2023239 · Received February 15, 2011

    Report

    Report Number
    3006560326-2011-00002
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 15, 2011
    Product Code
    GEI
    PMA / PMN Number
    072505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN FOR EVALUATION OF THE DEVICE. DHR WAS REVIEWED AND DEVICE MET RELEASE CRITERIA. ULTHERA TECHNICAL USER MANUAL CONTRAINDICATIONS STATE, "THE ULTHERA SYSTEM IS CONTRAINDICATED FOR USE IN PTS WITH OPEN FACIAL WOUNDS OR LESIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PT EXPERIENCED SKIN IRRITATION EFFECTS. TOPICAL ANESTHESIA AND A DERM ROLLER WERE USED DURING THE PROCEDURE. "THE DERMAROLLER (ALSO CALLED SKIN ROLLERS, MICRONEEDLE ROLLERS, AND DERMAROLLERS) IS A SMALL HAND-HELD ROLLING DEVICE WHICH HAS MICRO SURGICAL STEEL NEEDLES THAT REACH THE INNER SURFACE OF YOUR SKIN."

    Additional Manufacturer Narrative · 2

    AWAITING RETURN FOR EVALUATION OF THE DEVICE. DHR WAS REVIEWED AND DEVICE MET RELEASE CRITERIA. ULTHERA TECHNICAL USER MANUAL CONTRAINDICATIONS STATE, "THE ULTHERA SYSTEM IS CONTRAINDICATED FOR USE IN PTS WITH OPEN FACIAL WOUNDS OR LESIONS."

    Description of Event or Problem · 2

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PT EXPERIENCED SKIN IRRITATION EFFECTS. TOPICAL ANESTHESIA AND A DERM ROLLER WERE USED DURING THE PROCEDURE. "THE DERMAROLLER (ALSO CALLED SKIN ROLLERS, MICRONEEDLE ROLLERS, AND DERMAROLLERS) IS A SMALL HAND-HELD ROLLING DEVICE WHICH HAS MICRO SURGICAL STEEL NEEDLES THAT REACH THE INNER SURFACE OF YOUR SKIN..."

    Additional Manufacturer Narrative · 3

    AWAITING RETURN FOR EVALUATION OF THE DEVICE. DHR WAS REVIEWED AND DEVICE MET RELEASE CRITERIA. ULTHERA TECHNICAL USER MANUAL CONTRAINDICATIONS STATE, "THE ULTHERA SYSTEM IS CONTRAINDICATED FOR USE IN PTS WITH OPEN FACIAL WOUNDS OR LESIONS."

    Description of Event or Problem · 3

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PT EXPERIENCED SKIN IRRITATION EFFECTS. TOPICAL ANESTHESIA AND A DERM ROLLER WERE USED DURING THE PROCEDURE. "THE DERMAROLLER (ALSO CALLED SKIN ROLLERS, MICRONEEDLE ROLLERS, AND DERMAROLLERS) IS A SMALL HAND-HELD ROLLING DEVICE WHICH HAS MICRO SURGICAL STEEL NEEDLES THAT REACH THE INNER SURFACE OF YOUR SKIN..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTHERA DEEPSEE TRANSDUCER NONE GEI UT-3 DS 7-4.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    2 Other
    3