BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAVLIK HARNESS

    MDR report key: 430667 · Received November 27, 2002

    Report

    Report Number
    1035617-2002-00004
    Event Type
    Malfunction
    Date Received
    November 27, 2002
    Report Date
    November 4, 2002
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    IOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WEARING THE PAVLIK HARNESS CAME FOR A ROUTINE CHECK. WHEN REMOVING THE HARNESS, IT WAS NOTED THAT A STRING FROM THE FRONT VELCRO STRAP HAD CAUGHT ON THEIR CALF AND HAD ALLEGEDLY CAUSED A LACERATION. THE WOUND REQUIRED STERISTRIPS AND A COURSE OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAVLIK HARNESS HIP ABDUCTION DEVICE IOZ ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 DAY Required Intervention