BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET KNEE SLEEVE OPEN PATELLA

    MDR report key: 3784749 · Received May 1, 2014

    Report

    Report Number
    2028253-2014-00009
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    December 25, 2013
    Report Date
    May 1, 2014
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS INSPECTED UPON RECEIPT. BRACE APPEARED TO BE MODERATELY USED AND IN GOOD CONDITION. NO EVIDENCE OF MALFUNCTION OR DEFECT.

    Description of Event or Problem · 1

    PATIENT ALLEGES HE DEVELOPED A LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (LLE DVT) FROM USE OF PRODUCT. NO REPORT OF PRODUCT MALFUNCTION. THE PATIENT TORE HIS LATERAL MENISCUS OF L KNEE IN EARLY (B)(6). ON (B)(6) 201,3 THE PATIENT WAS INJECTED CORTISONE IN THE KNEE AND ALSO PLACED HIS LLE IN A FLEXIBLE KNEE BRACE. HE DID WELL UNTIL (B)(6) 2013 WHEN HE AWAKENED WITH SUDDEN ONSET OF A SWOLLEN L ANKLE AND PAINFUL L CALF. PATIENT WAS HOSPITALIZED OVERNIGHT, PLACED ON ANTICOAGULANT TREATMENT AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261318 BIOMET KNEE SLEEVE OPEN PATELLA KNEE SLEEVE OPEN PATELLA IQI BREG, INC. 130615

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention