BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORT HARD SOFT SPLINT

    MDR report key: 13618910 · Received February 28, 2022

    Report

    Report Number
    3011649314-2022-00024
    Event Type
    Injury
    Date Received
    February 28, 2022
    Report Date
    May 28, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K121365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THERE IS MORE INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THERE IS MORE INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. SUPPLIER (ERKODENT) REVIEWED THE ASSOCIATED MATERIAL LOT AND CONFIRMED NO MATERIAL DEFECTS OR CHANGES COULD BE DETECTED. NO MANUFACTURING DEVIATIONS OR ABNORMALITIES ARE KNOWN. E-PRO 4.0 - 11770201 (ERKOLOC-PRO) WAS MANUFACTURED FROM NOVEMBER 17, 2021 AND WAS ASSIGNED AN EXPIRATION OF NOVEMBER 2024. STOCK PRODUCT REVIEWED RESULTS: NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS: NO DEVICE HAS BEEN RETURNED FROM THE CUSTOMER AND NO PICTURE WAS PROVIDED BY THE CUSTOMER TO REVIEW. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. NO DEVICE HAS BEEN RETURNED FOR REVIEW. IFU 9091 REV 5.0 (COMFORT H/S BITE SPLINT INSTRUCTION FOR USE) STATES "BRUSH AND FLOSS YOUR TEETH BEFORE USE. RINSE MOUTH WELL WITH CLEAN WATER BEFORE INSERTING THE DEVICE. IF PATIENT USES MOUTHWASH, ALL TRACES OF MOUTHWASH SHOULD BE REMOVED BY THOROUGHLY RINSING OUT MOUTH WITH WATER. RINSE BITE SPLINT WELL WITH CLEAN, COOL WATER BEFORE AND AFTER USE. CLEAN BITE SPLINT WITH CLEAN, COOL WATER ONLY AND LET AIR DRY." IFU PROVIDES WARNING "DO NOT CLEAN OR SOAK IN MOUTHWASH; DO NOT USE DENTURE CLEANSER, HOT WATER, ALCOHOL, HYDROGEN PEROXIDE; DO NOT PLACE IN DIRECT SUNLIGHT". IT IS POSSIBLE THAT REACTIONS COULD BE CAUSED BY MOUTHWASH, TOOTHPASTE, OR SOAKING MATERIAL. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    DEVICE LABELING : COMFORT BITE SPLINTS ARE INTENDED TO BE USED ON A SINGLE PATIENT ONLY. THE REUSE OF SUCH DEVICE ON ANOTHER PATIENT IS NOT RECOMMENDED DUE TO THE RISKS OF IMPROPER FIT AND CROSS-CONTAMINATION/INFECTION. COMFORT BITE SPLINTS MAY ONLY BE USED FOR THEIR INTENDED USE IN ACCORDANCE WITH GENERAL RULES FOR DENTAL TREATMENT. IF THE INDICATIONS FOR USE ARE NOT CLEARLY SPECIFIED, TREATMENT SHOULD BE SUSPENDED UNTIL THOSE CONSIDERATIONS HAVE BEEN CLARIFIED. IRRITATION OF THE MOUTH, TONGUE, AND LIPS MAY OCCUR. REGULAR DENTAL FOLLOW-UPS ARE RECOMMENDED TO REVIEW ANY SIDE EFFECTS TO AVOID DEVICE BREAKAGE, ALLERGIC REACTION, IRRITATION, OR DISCOMFORT. A1 WAS CORRECTED IN THE PREVIOUS MEDWATCH REPORT BUT NOT REPORTED IN SECTION H11 CAPA (B)(4). MANUFACTURER REFERENCE: COMP (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905689 COMFORT HARD SOFT SPLINT THERMOFORM MQC PRISMATIK DENTALCRAFT, INC. E-PRO 4.0 - 11770201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other