BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCARE

    MDR report key: 4241129 · Received November 5, 2014

    Report

    Report Number
    9616086-2014-00018
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    August 26, 2014
    Report Date
    November 4, 2014
    Manufacturer
    DJO, LLC
    Product Code
    IOY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FORM PATIENT THAT ALLEGES "A PATIENT HAVE A SEVERE ALLERGIC REACTION TO THE SLING". QUESTIONNAIRE NOT RECEIVED FROM CLINICAL AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712144 PROCARE UNIVERSAL MESH SHOULDER IMMOBILIZER IOY DJO, LLC 79-84350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other