BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELB MOUTHGUARD

    MDR report key: 8500678 · Received April 10, 2019

    Report

    Report Number
    3011649314-2019-00056
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    February 25, 2019
    Report Date
    May 28, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K111828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, BUT DID NOT TRANSFER TO THE INVESTIGATOR. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DEVICE HISTORY RECORD REVIEWED: NO DHR WAS AVAILABLE FOR REVIEW BEING THAT THIS DEVICE WAS MANUFACTURED USING THE PHYSICIANS PRESCRIPTION ONLY. ASSOCIATED MATERIAL LOT IS NOT APPLICABLE AS THIS DEVICE IS NOT MANUFACTURED IN BULK AND BY RX ONLY. MANUFACTURING DEVIATION OR ABNORMALITIES COULD NOT BE CONFIRMED WITH SUPPLIER. STOCK PRODUCT REVIEWED: DEVICE WAS FABRICATED TO PHYSICIAN'S PRESCRIPTION THEREFORE NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW. RETURNED SAMPLE: DEVICE IN QUESTION WAS SCRAPPED BY PRODUCTION AFTER A NEW MOUTHGUARD WAS FABRICATED. ROOT CAUSE: THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. THE PATIENT WAS REPORTED TO HAVE NO PRE-EXISTING CONDITION OR ALLERGIES PRIOR TO THE DELIVERY OF THE DEVICE. PER PREMARKET NOTIFICATION 510(K) SUMMARY FOR CLEARSPLINT ES- ASTRON DENTAL CORP. (K111828), THE FOLLOWING STATEMENT IS LOCATED UNDER PROPOSED INSTRUCTION: "CAUTION: AN ALLERGY TEST IS RECOMMENDED PRIOR TO PLACING (APPLIANCE) IN A DENTAL CAVITY. HOWEVER, IT IS UNKNOWN IF THE PATIENT HAS ANY DENTAL OR MEDICAL HISTORY PRIOR TO THE DEVICE BEING PRESCRIBED. IN ADDITION, IT WAS UNKNOWN HOW THE PATIENT WAS INSTRUCTED TO MAINTAIN AND CLEAN THE DEVICE. PER PROPOSED INSTRUCTION PROVIDED FROM K111828, ASTRON DENTAL CORPORATION SUGGESTED "BRIEFLY PLACE APPLIANCE IN WARM TAP WATER BEFORE INSERTING IN MOUTH." PER SUPPLEMENT DATA FROM K111828, THE CLEARSPLINT WAS FOUND TO BE BIOCOMPATIBLE.

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. FOLLOW-UP WAS MADE TO REQUEST FOR DEVICE RETURN. THE OFFICE ADVISED THE DEVICE WAS ALREADY SENT OUT. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION WHILE WEARING A GELB MOUTHGUARD. THE PATIENT EXPERIENCED TINGLING, HIGH SENSITIVITY IN THE MOUTH AND TEETH PAIN IMMEDIATELY AFTER WEARING THE MOUTHGUARD. THE PATIENT EXPERIENCED THESE SYMPTOMS ONLY ON THE AREA MAKING CONTACT TO THE MOUTHGUARD'S METAL WIRE. UPON EXPERIENCING THE REACTION, THE PATIENT STOPPED WEARING IT IMMEDIATELY. THE SYMPTOMS RESOLVED THEMSELVES AFTER LESS THAN 3 DAYS. THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR THE REACTION. THE PATIENT WAS REPORTED TO BE DOING FINE. THE PATIENT HAS NO KNOWN PRE-EXISTING CONDITION OR ALLERGY. THE DOCTOR MADE SOME MINOR ADJUSTMENTS TO THE LINGUAL BUCCAL AREA OF THE MOUTHGUARD FOR BETTER FIT. THE PATIENT CLEANED THE MOUTHGUARD ONLY WITH WARM WATER AND TOOTHBRUSH. ANOTHER MOUTHGUARD, COMFORT BITE SPLINT, WAS MADE FOR THE PATIENT AND SHE HAS NOT HAD ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291522 GELB MOUTHGUARD GELB MOUTHGUARD MQC PRISMATIK DENTALCRAFT, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other