BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORT HARD-SOFT SPLINT

    MDR report key: 15331475 · Received August 31, 2022

    Report

    Report Number
    3011649314-2022-00484
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    July 29, 2022
    Report Date
    July 24, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K121365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. MODEL # IS NOT APPLICABLE WITH THE EXCEPTION OF SERIAL NUMBER AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION. IMPLANT DATE IS NOT APPLICABLE AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION AND NOT IMPLANTABLE.

    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 MANUFACTURING DEVIATION OR ABNORMALITY. LOT# E-PRO 4.0-11776202 (ERKOLOC-PRO) WAS MANUFACTURED FROM FEBRUARY 2022 AND WAS ASSIGNED AN EXPIRATION OF FEBRUARY 2025. STOCK PRODUCT REVIEWED RESULTS NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS: CUSTOMER HAS NOT RETURNED THE PRODUCT OR PROVIDED AN IMAGE FOR REVIEW. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. 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."

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: D4, H6 (HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION CODE, AND INVESTIGATION CONCLUSIONS CODE - 22). CORRECTED DATA: B2, D1, H6 (HEALTH EFFECT - IMPACT CODE, INVESTIGATION FINDINGS CODE, AND INVESTIGATION CONCLUSIONS CODE - 4315). 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. CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO COMFORT HARD SOFT SPLINT. THE PATIENT HAS NO MEDICAL HISTORY OR ALLERGIES NOTED PRIOR TO DELIVERY OF THE DEVICE. THE DEVICE WAS DELIVERED ON (B)(6) 2022 AND USED THE SAME EVENING. THE REACTION OCCURRED (B)(6) 2022. THE PATIENT EXPERIENCED BLISTERS ON THE INSIDE OF THE UPPER LIP. THE DEVICE WAS DISCONTINUED (B)(6) 2022 AND RESOLVED IN A DAY. THE PATIENT REQUIRED ORAJEL "SORE MOUTH GEL." THE STATUS IS NOTED AS "GOOD." WITH REGARDS TO THE DEVICE: THE DEVICE WAS CLEANED PRIOR TO DELIVERY, BUT THE METHOD IS NOT NOTED. THE PATIENT CLEANED THE DEVICE USING A TOOTHBRUSH AND "CREST" TOOTHPASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069843 COMFORT HARD-SOFT SPLINT THERMOFORM MOUTHGUARD MQC PRISMATIK DENTALCRAFT, INC. 11776202

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other| R