BEUDAMED
    FDA Adverse Event Other Summary report: N

    RING APPLICATOR

    MDR report key: 117352 · Received August 4, 1997

    Report

    Report Number
    1121753-1997-00017
    Event Type
    Other
    Date Received
    August 4, 1997
    Date of Event
    April 11, 1997
    Report Date
    August 4, 1997
    Manufacturer
    NUCLETRON BV
    Product Code
    HGD
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RING APPLICATOR PART #084.087 WAS PURCHASED 2/22/95 WITH THE MHDR UNIT AND WAS UNUSED UNTIL THE DATE OF THE REPORT TO NUCLETRON. ON THAT DATE, THE APPLICATOR WAS TAKEN FROM THE KIT WHERE IT WAS STORED, INSPECTED PRIOR TO CLINICAL USE, AT WHICH TIME THE RING END OF THE APPLICATOR BECAME DETACHED FROM THE APPLICATOR SHAFT. THE INCIDENT WAS REPORTED TO NUCLETRON AND A REPLACEMENT APPLICATOR WAS PROVIDED. IT WAS DETERMINED THAT TECH NOTE #300.048, WHICH INFORMS THE USER OF THE POSSIBILITY THAT THE RING MAY SEPARATE WAS DELIVERED TO THE CLINICIAN WHEN THE UNIT WAS COMMISSIONED. THIS TECH NOTE INSTRUCTS THE WELD AT THE SITE WHERE THE RING JOINS THE APPLICATOR SHOULD BE INSPECTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RING APPLICATOR GYNECOLOGICAL APPLICATOR (COMPONENT OF HGD NUCLETRON BV RING APPLICATOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other