{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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ON (B)(6) 2021 THE PATIENT'S FACE BECAME SWOLLEN AND THEY WENT TO THEIR PRIMARY CARE PHYSICIAN. THE PATIENT WAS GIVEN ANTIBIOTICS AND WENT HOME. ON (B)(6) 2021 THE PATIENT COULD NO LONGER OPEN THEIR JAW DUE TO SWELLING AND THEIR PRIMARY CARE PHYSICIAN SENT THEM TO THE ER WHERE THEY SPENT 6 DAYS IN THE HOSPITAL DUE TO CELLULITIS. THE PATIENT WAS ADVISED BY MULTIPLE DOCTORS THAT THEY MAY GET CELLULITIS AGAIN NOW THAT THEY HAVE HAD IT, AND SHOULD STOP TREATMENT." }, { "mdr_text_key": "285056582", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "EVALUATION OF RETURNED DEVICES: TRAYS 1U AND 2U HAVE PRESSURE DAMAGE ALONG THE UR2 AND UR3 TEETH. THIS TYPE OF DAMAGE USUALLY OCCURS DURING INCORRECT INSERTION TECHNIQUE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "591 YOSEMITE DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95035", "manufacturer_contact_exchange": "831", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }