BEUDAMED
    FDA Adverse Event Death Summary report: N

    I-LIMB ACCESS

    MDR report key: 17662188 · Received August 31, 2023

    Report

    Report Number
    3006532285-2023-00001
    Event Type
    Death
    Date Received
    August 31, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 12, 2024
    Manufacturer
    TOUCH BIONICS LTD.
    Product Code
    IQZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON INFORMATION PROVIDED, IT IS HEREIN CONCLUDED THAT THE I-LIMB ACCESS INVOLVEMENT IN THE INCIDENT IS UNLIKELY AS A CAUSE OR CONTRIBUTOR.

    Description of Event or Problem · 0

    A FIRE OCCURRED IN A HOUSE WHERE THE DEVICE WAS LOCATED. IT HAS BEEN REPORTED THAT 2 PEOPLE DIED AND 3 PEOPLE WERE INJURED AS A RESULT OF THE FIRE. THE CAUSE OF THE FIRE IS UNDER INVESTIGATION.

    Description of Event or Problem · 0

    A FIRE OCCURRED IN A HOUSE WHERE THE DEVICE WAS LOCATED. IT HAS BEEN REPORTED THAT 2 PEOPLE DIED AND 3 PEOPLE WERE INJURED AS A RESULT OF THE FIRE. THE CAUSE OF THE FIRE IS UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124892 I-LIMB ACCESS PROSTHETIC HAND IQZ TOUCH BIONICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| D