BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM DIAMOND BALL, 15CM

    MDR report key: 3067357 · Received April 12, 2013

    Report

    Report Number
    1045834-2013-01647
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CUSTOMER REPORTED TWO OCCURRENCES OF THE REPORTED CONDITION AND RETURNED FOUR SAMPLES. THE SAMPLES WERE EXAMINED BY RELIABILITY ENGINEERING. VISUAL INSPECTION REVEALED THAT THE PACKAGING WAS IN GOOD CONDITION WITH NO DEFECTS OF THE PEELABLE OR TERMINAL SEALS. THE PACKAGING WAS INSPECTED UNDER 10X MAGNIFICATION, AND FOREIGN MATERIAL WAS NOT OBSERVED IN THE PACKAGING. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY. REF: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT 1 OF 2. REPORT RECEIVED FROM (B)(6), STATING THAT THERE WAS "RESIDUE FOUND IN THE STERILE PACK" OF THE DEVICE, DISCOVERED DURING INSPECTION. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THER WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159672 3MM DIAMOND BALL, 15CM HBE THE ANSPACH EFFORT, INC. F313068401

    Patients

    Seq Age Sex Outcome Treatment
    1