BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINUET II ACCESSORY

    MDR report key: 2111015 · Received April 21, 2011

    Report

    Report Number
    3003984900-2011-00008
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN SHIPPED TO (B)(6) CUSTOMERS, (B)(4). THERE IS A RISK OF THE KNOBS BEING DAMAGED IN USE AND CAUSING INJURY TO CARERS OR PTS DUE TO THE SHARP EDGES THAT CAN BE PRODUCED WHEN THE PART SUFFERS IMPACT DAMAGE. FURTHER INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    PART (B)(4) HAS BEEN TRANSFERRED TO NEW SUPPLIER IN (B)(6) UNDER (B)(6). THIS CHANGE IS STILL IN PROGRESS AND NO CONCESSION HAS BEEN RELEASED TO APPROVE SHIPMENT. DURING PRODUCTION SAMPLE EVALUATION, PART OF THE PRODUCT WAS FOUND TO BE DEFECTIVE WHEN UNWRAPPED PRIOR TO ANY TESTING. THE ADJUSTABLE KNOB HAD BEEN CATASTROPHICALLY DAMAGED DURING TRANSIT LEAVING VERY SHARP EDGES. THE MATERIAL USED FOR THE KNOBS IS NOT TO SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINUET II ACCESSORY LIFTING & EQUIPMENT RAIL ACCESSORIES FSA ARJOHUNTLEIGH CM-ACC23

    Patients

    Seq Age Sex Outcome Treatment
    1 Other