BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY® P3, SERVICE TEST CASE

    MDR report key: 5806159 · Received July 19, 2016

    Report

    Report Number
    1721652-2016-00002
    Date Received
    July 19, 2016
    Date of Event
    April 22, 2016
    Report Date
    June 21, 2016
    Manufacturer
    OTTO BOCK HEALTHCARE LP
    Product Code
    ISP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT OCCURRED OVERSEAS IN (B)(6) AND HAS BEEN TRANSLATED ACCORDINGLY PER OUR AFFILIATES IN EUROPE: A LOANER SYSTEM WAS PROVIDED TO THE CUSTOMER IN ORDER TO FIT THE PATIENT WITH SO THAT THE PATIENT WAS NOT IMMOBILIZED DURING HIS/HER REPAIRS. PER THE PROVIDED LOANER KIT, MULTIPLE FUNCTIONAL RINGS ARE PROVIDED IN ORDER TO ALLOW THE CUSTOMER TO CHOOSE THE MOST APPROPRIATE FITTING FOR THE PATIENT BASED ON STIFFNESS. THE CUSTOMER DID NOT FOLLOW THE PROVIDED INSTRUCTIONS AND IFU AND DID NOT APPROPRIATELY TIGHTEN THE FUNCTIONAL RING TO THE PUMP SYSTEM WHICH IS A REQUIREMENT AS SPECIFIED IN THE INSTRUCTIONS FOR USE. THE PATIENT WAS USING THE PRODUCT AND WHILE IN USE THE FUNCTIONAL RING BECAME DETACHED FROM THE PUMP SYSTEM AND THE PATIENT FELL TO THE GROUND. ACCORDING TO THE INITIAL REPORTER, THE FALL CAUSED THE PATIENT TO FRACTURE HIS/HER SHOULDER. FOLLOW-UP WITH REGARD TO THE HEALTH OF THE PATIENT HAS BEEN ONGOING. AT THIS POINT, MULTIPLE ATTEMPTS TO GAIN THE ADDITIONAL INFORMATION RELATED TO AGE, WEIGHT, HEIGHT, PATIENT SEX AND OVERALL EVENT DETAILS HAVE BEEN REQUESTED. ALL OF THIS INFORMATION HAS BEEN DOCUMENTED IN THE RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457768 HARMONY® P3, SERVICE TEST CASE VALVE, PROSTHESIS ISP OTTO BOCK HEALTHCARE LP 4R147=S

    Patients

    Seq Age Sex Outcome Treatment
    1