BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2625794 · Received May 12, 2009

    Report

    Report Number
    8010704-2009-00001
    Event Type
    Other
    Date Received
    May 12, 2009
    Manufacturer
    NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH
    Product Code
    KBN
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE REPEATED ATTEMPTS OF OUR DISTRIBUTOR, THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE DENTIST INVOLVED IN THIS INCIDENT, IS RELUCTANT TO RETURN THE INSTRUMENT BECAUSE IT IS NEEDED. IT WAS PURCHASED TWO YEARS AGO AND ACCORDING TO THE INFO RECEIVED, FUNCTIONS PERFECTLY. THE TIP THAT WAS RETRIEVED IN SUBJECT PROCEDURE, WAS REPLACED BY ANOTHER AND THE INSTRUMENT CONTINUES TO BE IN USE AT THIS DENTAL PRACTICE. THIS MEANS THAT INSTRUMENT FAILURE CAN BE ELIMINATED AS A POSSIBLE CAUSE. NEVERTHELESS, WE HAVE REVIEWED OUR PRODUCTION RECORDS. LOT NR. 03/05P IDENTIFIES THE INSTRUMENT AS A NOPA DEVICE PRODUCED FOR (B)(4). PRODUCTION STARTED IN (B)(4) 2004. SINCE THEN A TOTAL OF (B)(4) INSTRUMENTS HAVE BEEN SHIPPED. THIS IS THE FIRST EVENT INVOLVING ONE OF THESE INSTRUMENTS. IT HAS PREVIOUSLY BEEN SUGGESTED TO SHIP THESE DEVICES WITHOUT THE PLASTIC TIPS. HOWEVER, THEY ARE ATTACHED TO PREVENT DAMAGE TO SENSITIVE MOUTH TISSUES AND HAVE TO BE REMOVABLE FOR PROPER CLEANING. IN MARKETING THE DEVICE, CLIENTS SHOULD POSSIBLY BE ALERTED TO THE FACT THAT THE SILICONE TIPS HAVE KNOWN TO COME OFF WHEN TREATING CHILDREN. IT SHOULD THEN BE AT THE DENTIST'S DISCRETION TO DECIDE WHETHER OR NOT TO USE THEM WITH YOUNG PATIENTS. NOPA KNOWS OF ONLY ONE OTHER INCIDENT WITH A COMPETITIVE DEVICE WHERE THE TIPS WERE SWALLOWED (SEE 8010704-2008-00001 INVOLVING A (B)(6) SPECIAL NEEDS YOUNGSTER).

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KBN NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1