BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE GRIPPER II

    MDR report key: 29122 · Received December 8, 1995

    Report

    Report Number
    1417592-1995-09059
    Event Type
    Injury
    Date Received
    December 8, 1995
    Date of Event
    December 4, 1995
    Report Date
    December 8, 1995
    Manufacturer
    MEDLINE IND.
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NURSE SLIPPED AND FELL ON OR FLOOR WHILE WEARING SHOECOVERS. SUSTAINED TWISTED ANKLE. NURSE WAS GIVEN XRAYS. XRAYS WERE NEGATIVE. LABELING STATES "PERSONNEL WHO WEAR SHOE COVERS SHOULD BE AWARE THAT A RISK OF SLIPPING EXISTS AND SHOULD TAKE PRECAUTIONS TO AVOID MISUSE OF SHOE COVERS".DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE GRIPPER II SHOE COVERS FXP MEDLINE IND. 62714

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention