BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS

    MDR report key: 14239290 · Received April 28, 2022

    Report

    Report Number
    3011649314-2022-00221
    Event Type
    Injury
    Date Received
    April 28, 2022
    Report Date
    July 23, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K083209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THIS INFORMATION WAS NOT PROVIDED WHEN ASKED. THE PATIENTS WEIGHT IS NOT PROVIDED WHEN ASKED. THIS INFORMATION WAS NOT PROVIDED WHEN ASKED. THIS INFORMATION WAS NOT PROVIDED WHEN ASKED. IS NOT APPLICABLE WITH THE EXCEPTION OF SERIAL NUMBER AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION. IS NOT APPLICABLE AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION AND NOT IMPLANTABLE.

    Additional Manufacturer Narrative · 0

    CAPA 2023-006 THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR CASE#(B)(4) AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. ORTHOBNDLOT# 0020210923 (ORTHO BAND) BCLASPLOT# 077403-14-1 (BALL CLASP) ARMSLOT# 1203108 (HINGE) PIVOTLOT# 1071012-2 (PIVOT) SCREW LOT# 1080412 (SCREW) ACRYLIC NUT LOT#1110412 (ACRYLIC NUT) LOT# EP4MM11615 (E-PRO 4MM, UPPER) LOT# EP4MM11615 (E-PRO 4MM, LOWER) STOCK PRODUCT REVIEWED RESULTS NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS COMPLAINT INVESTIGATOR REVIEWED THE RETURNED DEVICE. PRODUCT WAS RETURNED IN THE ORIGINAL CASE. ROUGHNESS - THE FLANGE WAS SMOOTH; INTERNAL/EXTERNAL SURFACES WERE SMOOTH. CRACK - NO CRACK WAS FOUND. DELAMINATION - LAYERS WERE INTACT AND DID NOT SEPARATE. DISCOLORATION - THE DEVICE APPEARED DISCOLORED DUE TO THE USAGE. GENERAL CLEANLINESS - THE RETURNED DEVICE WAS OBSERVED CLEAN. CASE WAS RETURNED INTACT. THE RETURNED DEVICE WAS VISUALLY 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. PER THE REPORTED INFORMATION, THE PATIENT IS NOTED TO HAVE AN ALLERGY TO NICKEL. IFU 102523 REV 3 (OASYS INSTRUCTION FOR USE) CLEANING PROCEDURES: BRUSH AND FLOSS 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. BRUSH THE DEVICE CAREFULLY WITH A SOFT TOOTHBRUSH AND COOL WATER. DO NOT USE SOAP TO CLEAN APPLIANCE. MINIMIZE ODOR BY LETTING THE DEVICE DRY DURING THE DAY WITH THE CONTAINER LID OPEN. IFU 102523 REV 3 (OASYS INSTRUCTION FOR USE) PROVIDES WARNING: DEVICE CONTAINS NICKEL. DENTISTS SHOULD CONSIDER THE MEDICAL HISTORY OF THE PATIENTS, INCLUDING ALLERGIC REACTIONS, HISTORY OF ASTHMA, BREATHING, OR RESPIRATORY DISORDERS, OR OTHER RELEVANT HEALTH PROBLEMS AND REFER THE PATIENT TO THE APPROPRIATE HEALTHCARE PROVIDER BEFORE PRESCRIBING THE DEVICE. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B2, E1, H6. CAPA 23-006. G3 WAS INADVERTENTLY REPORTED IN THE PREVIOUS REPORT AS 04/09/2023, HOWEVER, THE CORRECT DATE IS 01/17/2024. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE OASYS DEVICE THAT WAS ISSUED. IT IS UNCLEAR WHEN THE PATIENT RECEIVED THE DEVICE, WHEN THE PATIENT FIRST USED THE DEVICE, OR WHEN THE REACTION OCCURRED OR RESOLVED. HOWEVER, IT IS NOTED THAT THE PATIENT EXPERIENCED THROAT SWELLING TO INCLUDE THE UVULA, SWELLING, AND ITCHING OF THE TONGUE. THE DEVICE WAS WORN FOR 5 NIGHTS. THE PATIENT TOOK BENADRYL TO REDUCE THE SYMPTOMS. THE PATIENT IS NOTED TO HAVE AN ALLERGY TO NICKEL. THE PATIENT WAS ADVISED TO STOP USING THE APPLIANCE AND RETURN APPLIANCE FOR FURTHER RESEARCH AND TO OBTAIN AN ALLERGY TEST WITH THEIR MEDICAL PROVIDER FOR DEFINITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190173 OASYS ANTI-SNORING LRK PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other