BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHEIN - 4 TARTAR AND STAIN REMOVER

    MDR report key: 3041964 · Received March 31, 2013

    Report

    Report Number
    1925223-2013-00049
    Event Type
    Injury
    Date Received
    March 31, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    HERAEUS KULZER, INC.
    Product Code
    FLG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLAINT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. RESULTS - THE CUSTOMER ADDED THIS TO A BOTTLE THAT HAD BEEN USED FOR CAVICIDE DISINFECTANT BY METREX. THE TARTAR AND STAIN REMOVER WAS NOT INDICATED FOR USE WITH ANY OTHER SOLUTIONS. IT IS UNKNOWN WHAT THE ADVERSE EFFECTS OF THE MIXTURE OF CAVICIDE AND TARTAR AND STAIN REMOVER AS THEY ARE NOT INDICATED FOR USE AS A MIXED SOLUTION. CONCLUSION - THE DIRECTIONS FOR USE STATES TO USE IN A GLASS BEAKER WITH A LID AND THERE ARE NO DIRECTIONS FOR ADDING IT TO A SPRAY BOTTLE FOR USE AS A SPRAY. THE DENTAL OFFICE EMPLOYEES ARE AWARE THAT THIS IS NOT THE APPROPRIATE USE FOR THE TARTAR AND STAIN REMOVER AND MENTIONED THAT THEY DID NOT INFORM THE DENTIST BECAUSE THEY DID NOT WANT THE COWORKER TO GET IN TROUBLE. THE CAUSE OF THE ADVERSE EVENT WAS USER ERROR AND IT IS FOR THE AFOREMENTIONED REASON THAT NO CAPA MEASURES WILL BE INITIATED.

    Description of Event or Problem · 1

    HENRY SCHEIN REGULATORY DEPARTMENT EMAILED AN ADVERSE EVENT NOTIFICATION. SCHEIN REPORTED THAT A DENTAL HYGIENIST REPORTED THAT ONE OF HER COWORKERS MIXED THE CAVICIDE BY METREX WITH THE TARTER AND STAIN REMOVER AND WHEN SHE SPRAYED IT SHE STARTED COUGHING CONSISTENTLY AND HER THROAT IS IRRITATED AND SHE HAD A BAD TASTE IN HER MOUTH. THE COVER LETTER STATES: OUR CUSTOMER WILL NOT BE RETURNING THE AFFECTED PRODUCT, THEREFORE, NO PRODUCT WILL BE RETURNED FOR EVALUATION. CONTACTED THE HYGIENIST WHO SAID THE T AND S REMOVER WAS ACCIDENTALLY PUT INTO HER CAVICIDE BOTTLE WHEN THE COWORKER REFILLED BOTTLE FOR HER. SHE SAID THEY HAVE NOT TOLD THE DENTIST AS THEY DID NOT WANT THE COWORKER TO GET IN TROUBLE. SHE SAID SHE HAS NOT BEEN TO THE DOCTOR YET BUT SHE DID CALL HER DOCTOR AND POISON CONTROL. POISON CONTROL TOOK A REPORT AND HER DOCTOR RECOMMENDED IBUPROFEN. SHE WILL GO IN TODAY. SHE SAID THEY TOLD HER THEY WILL PRESCRIBE A STEROID TO HELP WITH THE SYMPTOMS. SHE SAID SHE HAS BEEN DRINKING AND EATING COLD THINGS TO HELP WITH THE IRRITATION OVER THE WEEKEND. SHE DESCRIBED THE SYMPTOMS AS VERY SORE/IRRITATED THROAT WITH SLIGHT SWELLING. SHE SAID SHE CAN EAT, DRINK AND SWALLOW JUST FINE. SHE SAID SHE HAS HAD NO TROUBLE BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131395 SCHEIN - 4 TARTAR AND STAIN REMOVER FLG CLEANER, ULTRASONIC, MEDICAL INSTRUM FLG HERAEUS KULZER, INC. 50036503

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention