BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOBAND

    MDR report key: 286241 · Received July 13, 2000

    Report

    Report Number
    3026511-2000-00001
    Event Type
    Other
    Date Received
    July 13, 2000
    Date of Event
    December 30, 1999
    Report Date
    July 12, 2000
    Manufacturer
    INNOVATIONS FOR ACCESS
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON 12/30/99 THE PT HAD CHEST PAIN AND WAS CATHETERIZED FOR AN ANGIOGRAM STUDY. THE PT HAD SUBSEQUENT STENTING WHICH REDUCED STENOSIS 80% TO 0% RESIDUAL. POST-CATHETERIZATION, A HEMOBAND WAS USED ON THE CATHETERIZATION SITE TO PROVIDE HEMOSTASIS. PT LATER COMPLAINED OF BACK PAIN AND NUMBNESS IN LEFT LEG AND RIGHT HAND. THE HEMOBAND WAS LEFT IN PLACE THREE HOURS PER DOCTOR'S INSTRUCTION. PT HAD SUBSEQUENT CARPAL TUNNEL SURGERY ON THEIR RIGHT WRIST IN JANUARY 2000 AND APPROXIMATELY SIX WEEKS LATER WHILE DOING YARD WORK "SOMETHING POPPED" AND PT HAD ANOTHER SURGERY FOR DECOMPRESSION OF THE CARPAL TUNNEL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOBAND HEMSTASIS KOC INNOVATIONS FOR ACCESS 8500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability XANAX, PRINIVIL, DIOVAN, CARDIZEM CD, NEURONTIN,| CELEBREX, LASIX, LIPITOR, VALIUM, BENEDRYL,| REGLAN, DOLAUDID, VITAMIN C, VITAMIN B, ANCEF.| HEPARIN, VICODIN, INSULIN, ASPIRIN, AMITRIPTYLINE,