BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORT HARD-SOFT BITE SPLINT

    MDR report key: 11100626 · Received December 31, 2020

    Report

    Report Number
    3011649314-2020-00756
    Event Type
    Injury
    Date Received
    December 31, 2020
    Report Date
    August 3, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K121365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION 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-PRO4.0-11343 (ERKOLOC-PRO) WAS MANUFACTURED FROM 10/28/19 AND WAS ASSIGNED WITH 3 YEARS EXPIRATION. STOCK PRODUCT REVIEWED RESULTS: NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS: DEVICE WAS NOT RETURNED FOR INVESTIGATION. ROUGHNESS - IT WAS DIFFICULT TO EVALUATE, BUT THE SURFACES AND FLANGE OF THE DEVICE APPEARED SMOOTH. CRACK - NO MAJOR CRACK WAS NOTICED IN THE IMAGES PROVIDED. DELAMINATION - LAYERS APPEARED INTACT AND NOT SEPARATED. DISCOLORATION - THE DEVICE APPEARED DISCOLORED. A YELLOWISH TINT APPEARED TO HAVE DEVELOPED DUE TO NORMAL USAGE. GENERAL CLEANLINESS - CLEANLINESS COULD NOT BE DETERMINED VIA PHOTOS. THE IMAGES PROVIDED WERE INSPECTED AND NO DEFECT OR ABNORMALITY WAS OBSERVED. THERE WAS NO EVIDENCE FOUND TO INDICATE THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF ROOT CAUSE: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. IFU 9091 REV 3.0 (COMFORT H/S BITE SPLINT INSTRUCTION FOR USE) STATES TO USE ONLY CLEAR, COOL WATER TO WASH THE DEVICE. 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. HOWEVER, THE CUSTOMER DID NOT PROVIDE THE INFORMATION REGARDING HOW THE PATIENT HANDLED AND MAINTAINED THE DEVICE. SUPPLIER ERKODENT REVIEWED THE INCIDENT DETAILS AND DETERMINED AN ALLERGIC REACTION COULD NOT BE RULED OUT. GLIDEWELL RESEARCH TEAM AND NAMSA CONDUCTED A SERIES OF TESTING ON A SIMILAR THERMOFORMED SLEEP DEVICE FOLLOWING ISO 10993 (BIOLOGICAL EVALUATION OF MEDICAL DEVICES) AND THE DEVICE WAS EVALUATED FOR POTENTIAL CYTOTOXICITY, SKIN IRRITATION, DELAYED DERMAL CONTACT SENSITIZATION AND ORAL MUCOSAL IRRITATION. THE TEST ARTICLE WAS THERMOFORMED WITH LAYERS OF ERKODENT MATERIAL (ERKOLOC-PRO AND ERKODUR). THE TEST RESULTS WERE LISTED BELOW AND SUMMARIZED IN BIOCOMPATIBILITY REPORT FOR SLEEP DEVICE (RPT 9733 REV 1.0) · FOR CYTOTOXICITY TESTING, THE TEST ARTICLE EXTRACT SHOWED NO EVIDENCE OF CAUSING CELL LYSIS OR TOXICITY. · FOR SKIN IRRITATION, THERE WAS NO ERYTHEMA AND NO EDEMA OBSERVED ON THE SKIN OF THE ANIMALS TREATED WITH THE TEST ARTICLE. · FOR SENSITIZATION TESTING, THE TEST ARTICLE EXTRACTS SHOWED NO EVIDENCE OF CAUSING DELAYED DERMAL CONTACT SENSITIZATION. · THE TEST ARTICLE SHOWED NONIRRITANT TO THE ORAL MUCOSA AS COMPARED TO THE CONTROL ARTICLE. THE DEVICE MATERIALS HAVE BEEN FOUND TO BE BIOCOMPATIBLE THROUGH THE TESTING. THERE WAS NO CYTOTOXIC, SENSITIZATION, SKIN IRRITATION, OR ORAL MUCOSAL IRRITATION FOUND IN ANY OF THE TEST ARTICLES.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE COMFORT HARD SOFT SPLINT. THE REACTION WAS LOCATED ON THE INTRAORAL, AND LIPS. SPECIFICALLY, IT IS NOTED THAT THE PATIENT EXPERIENCED BURNING SENSATION AND SWELLING ON LIPS, CHEEK AND TONGUE. THE PATIENT NOTICED IT THE MORNING AFTER THE FIRST USE. THE REACTION LASTED A FEW DAYS AFTER. THE PROVIDER IS UNSURE HOW MANY TIMES THE PATIENT USED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566188 COMFORT HARD-SOFT BITE SPLINT THERMOFORM MOUTHGUARD MQC PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention