BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASHION ARM SLING, LARGE BOX 10

    MDR report key: 2912795 · Received January 8, 2013

    Report

    Report Number
    1526350-2013-00009
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    ILI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ARM SLING WAS IRRITATING TO A PATIENT AS THE ARM SLING WAS REPORTED TO BE MADE FROM A DIFFERENT MATERIAL. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10331 FASHION ARM SLING, LARGE BOX 10 FASHION ARM SLING, LARGE BOX 10 ILI ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1