BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICEROSS SEAL-IN V 34

    MDR report key: 6033583 · Received October 17, 2016

    Report

    Report Number
    3003764610-2016-00007
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 17, 2016
    Manufacturer
    OSSUR ICELAND
    Product Code
    ISH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BELOW KNEE AMPUTEE PATIENT WEARING THE ICEROSS SEAL IN V 34 PRODUCT SPENT SEVERAL HOURS IN A PUB WHERE HE SAT FOR ABOUT TWO HOURS. AS HE GOT UP, THE SOCKET OF THE STUMP SLIPPED. THE LINER REMAINED AT THE STUMP. HE AND A GLASS BOTH FELL TO THE GROUND WHERE HE INJURED HIS HAND ON THE BROKEN GLASS AND LOST A PART OF HIS FINGER. THE PATIENT SPENT A WEEK IN THE HOSPITAL AND HAD HIS FINGER TIP REATTACHED. THE PATIENT LOST HIS FINGER NAIL.

    Description of Event or Problem · 1

    A BELOW KNEE AMPUTEE PATIENT WEARING THE ICEROSS SEAL IN V 34 PRODUCT SPENT SEVERAL HOURS IN A PUB WHERE HE SAT FOR ABOUT TWO HOURS. AS HE GOT UP, THE SOCKET OF THE STUMP SLIPPED. THE LINER REMAINED AT THE STUMP. HE AND A GLASS BOTH FELL TO THE GROUND WHERE HE INJURED HIS HAND ON THE BROKEN GLASS AND LOST A PART OF HIS FINGER. THE PATIENT SPENT A WEEK IN THE HOSPITAL AND HAD HIS FINGER TIP REATTACHED. THE PATIENT LOST HIS FINGER NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686006 ICEROSS SEAL-IN V 34 SILICONE PROSTHETIC LINER ISH OSSUR ICELAND I-471334 HF160725

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention