BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICEROSS SEAL-IN X

    MDR report key: 8132735 · Received December 5, 2018

    Report

    Report Number
    3003764610-2018-00007
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    June 30, 2017
    Report Date
    December 5, 2018
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    PMA / PMN Number
    EXCEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO INDICATION OF MATERIAL OR MANUFACTURING FAILURE COULD BE IDENTIFIED BASED ON INFORMATION PROVIDED. THIS TYPE OF ISSUE HAS NOT BEEN RECORDED BEFORE AS A RESULT OF THIS OR PREDICATE DEVICES. NO PRODUCT WAS RETURNED AND ANALYSIS WAS PERFORMED BASED ON INFORMATION PROVIDED VIA MEDWATCH. IT IS CONCLUDED THAT THE SUBJECT IS LIKELY TO HAVE AN UNDERLYING CONDITION LEADING TO THE SEVERITY OF ULCERATION. DIABETIC PATIENTS AND PERIPHERAL VASCULAR DISEASE PATIENTS ARE KNOWN TO BE ULCER PRONE WHICH MAY ALSO HAVE CONTRIBUTED TO SAID ISSUE. AS INFORMATION IS SCARCE IN THE CLAIM AND RELATION CANNOT BE MADE TO PRODUCT MALFUNCTION, FURTHER ACTION IS NOT CONSIDERED WARRANTED.

    Description of Event or Problem · 1

    PATIENT WAS FITTED WITH A 1 1/2 IN SILICONE BAND THAT FELT LIKE A "TOURNIQUET", CAUSED PAIN AND DEVELOPED A NON-HEALING BLOOD BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971836 ICEROSS SEAL-IN X LINER ISH OSSUR HF I-SXT026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention