BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4113846 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00182
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2012
    Report Date
    April 29, 2014
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K091792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS NOT BEEN CONFIRMED. DEVICE NOT RETURNED TO MFR. NO INJURY WAS REPORTED, NO MED ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A POSSIBLE DELAMINATION, AS CHOKING IS POSSIBLE AS A RESULT OF DELAMINATION.

    Description of Event or Problem · 1

    ENGINEER A UNIT THAT HAS NO HIT OR MISS WHEN SETTING IN MOUTH SO IT DOES NOT COME APART! DO NOT HAVE PROOF OF PURCHASE, RECEIPT. NEVER HAD AN ISSUE WITH ANY OF THE OTHERS THAT I HAVE HAD. THIS MUST BE MY TENTH SET. THREW OUT RECEIPT. PER CUSTOMER LETTER TO CUSTOMER SERVICE: I HAVE BEEN TRYING TO TOUCH BASE FOR WEEKS NOW. THIS IS IN REGARDS TO THE (DENTAL GUARD) PROTECTORS WHICH HAVE COME APART ON ME. I HAVE SENT THESE BACK TO YOU, THE BROKEN ONE IS IN THE PROTECTIVE CASE, MARKED, DEFECTIVE PART. I HAVE GOTTEN TO THE POINT THAT, I JUST DO NOT CARE ANY LONGER, WHETHER SOMETHING GETS DONE OR NOT. I DO NOT HAVE THE RECEIPT FOR THE PURCHASE OF THIS. I HAVE USED THESE FOR MANY YEARS WITH NOT A SINGLE PROBLEM, SO I DID NOT KEEP IT. IF YOU CAN DO ANYTHING FOR ME I WOULD APPRECIATE IT, IF NOT I WILL JUST WRITE IT OFF AS A (NO BIG DEAL). I HAVE APPRECIATED YOUR PHONE MESSAGES AND CONCERN, BUT WE ARE GETTING NOWHERE. I RETURN THEM AND YOU'RE NEVER THERE OR I JUST LEAVE ANOTHER MESSAGE, AND THEN YOU LEAVE ME ONE BACK. THIS HAS BEEN JUST A ROUND ROBIN TYPE ORDEAL. ALTHOUGH WHEN SOMEONE SENDS ME AN EMAIL, ONE OF TWO THINGS MAY HAPPEN. FIRST, IF I DO NOT RECOGNIZE THE SENDER, I DELETE IT DUE TO SECURITY AND VIRUS PROTECTION. SECOND, IF MY COMPUTER PICKS IT UP AS SPAM, IT IS SENT TO JUNK MAIL. ANYHOW, I OBTAINED YOUR ADDRESS FROM YOUR OPERATOR THERE AND SHE GAVE ME THIS ADDRESS AND THE PROPER SPELLING OF YOUR LAST NAME, WHICH I NEVER HAD. WELL, IF YOU READ THIS YOU HAVE THE DEFECTIVE PART IN FRONT OF YOU, SO DO WHATEVER YOU DEEM NECESSARY, I HAVE GIVEN UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262618 NITE GUARD OBR RANIR LLC GEN II ORIG LOT 423013

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening