{
  "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 621
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Other",
      "report_number": "2914019-2008-00002",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20080208",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K003614",
      "date_of_event": "20080109",
      "reprocessed_and_reused_flag": "",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "User facility"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20080702",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080208",
          "brand_name": "LIGHTSHEER",
          "generic_name": "SOLID STATE AESTHETIC LASER",
          "manufacturer_d_name": "RH-USA, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "LIVERMORE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "LIGHTSHEER",
          "catalog_number": "50-05345",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "date_returned_to_manufacturer": "20080129",
          "device_report_product_code": "GEX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Powered Laser Surgical Instrument",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Unknown (for use when the device problem is not known)"
      ],
      "reporter_state_code": "AZ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250805",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20080208",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "50 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Blister(s)",
            "Pain",
            "Skin Discoloration",
            "Wheal(s)",
            "Impaired Healing",
            "Treatment with medication(s)"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080129",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1002866",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080110",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "20887538",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT 3 PATIENTS AND THE AESTHETICIAN EXPERIENCED WELTS AND BLISTERS FOLLOWING HAIR REMOVAL TREATMENT WITH LIGHTSHEER ET. ALL PERSONS HAD PREVIOUSLY TOLERATED THE SETTINGS USED ON THE INCIDENT DATE WITH NO PROBLEMS. PATIENT #2 IS FEMALE, SKIN TYPE II-III, WHO HAD HAIR REMOVAL TREATMENT ON HER UNDERARMS AND BIKINI AT 44J, 30MS AND 45J, 30MS, RESPECTIVELY. PATIENT NOTED THAT THE TREATMENT HURT MORE THAN USUAL. WITHIN 24 HOURS THE PATIENT REPORTED BLISTERS AND WELTS. PATIENT #2 WAS GIVEN STEROID CREAM. AS OF THE REPORT, PATIENT STILL HAS BROWN CIRCLES IN BIKINI AREA THAT ARE SLOWLY HEALING AND FADING."
        },
        {
          "mdr_text_key": "21122715",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ROOT CAUSE WAS DETERMINED TO BE USER ERROR IN NOT MAINTAINING THE DEVICE. REGULATORY INSPECTION UPON ARRIVAL OF UNIT AT DEPOT FOUND A SPOT IN SAPPHIRE TIP AND SPOTS ON THE ENERGY METER GLASS. BOTH WERE CLEANED THOROUGHLY. AN MDR WILL BE FILED DUE TO MEDICAL INTERVENTION AND DIRTY TIP AS AGREED UPON WITH THE DISTRICT OFFICE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}