{
  "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": 69
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
      "manufacturer_contact_state": "MA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "NEEDHAM",
      "manufacturer_contact_address_1": "89 A ST #100",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "3013738756-2025-00005",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20250401",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K242796",
      "date_of_event": "20250220",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "02494",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "SHAH",
      "source_type": [
        "Foreign",
        "Consumer"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "02494",
      "manufacturer_g1_state": "MA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20250401",
      "manufacturer_contact_f_name": "CHIRAG",
      "previous_use_code": "U",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2878388",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20250401",
          "brand_name": "SHARK CRYOGLOW",
          "generic_name": "LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION",
          "manufacturer_d_name": "SHARKNINJA OPERATING LLC",
          "manufacturer_d_address_1": "89 A ST #100",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "NEEDHAM",
          "manufacturer_d_state": "MA",
          "manufacturer_d_zip_code": "02494",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "02494",
          "device_operator": "LAY USER/PATIENT",
          "model_number": "FW312UKPL",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "OHS",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Light Based Over The Counter Wrinkle Reduction",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Patient Device Interaction Problem",
        "Patient Device Interaction Problem"
      ],
      "reporter_state_code": "MA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250822",
      "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": "20250401",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Skin Discoloration",
            "Skin Burning Sensation",
            "Skin Discoloration",
            "Skin Burning Sensation"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20250401",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "NEEDHAM",
      "mdr_report_key": "21739101",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250220",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "02494",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "SHARKNINJA OPERATING LLC",
      "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": "367125837",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THIS EVENT OCCURRED WITH A SIMILAR DEVICE IN A FOREIGN MARKET AND WAS NOT INITIALLY DETERMINED TO BE REPORTABLE IN THE US. AFTER REVIEW AND DETERMINATION THAT THE EVENT MET THE CRITERIA FOR US REPORTABILITY THIS REPORT IS BEING SUBMITTED WITHOUT UNDUE DELAY."
        },
        {
          "mdr_text_key": "367125838",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE CUSTOMER STATED THAT THE MASK HAS DAMAGED THEIR SKIN. THEY CONSIDER THIS ABNORMAL BECAUSE THEY HAVE USED LED MASKS BEFORE AND HAVE NOT HAD THIS REACTION FURTHER, THEY STILL ARE EXPERIENCING SKIN DAMAGE 4 DAYS LATER. THEIR SKIN IS HOT, FEELS TIGHT WHEN THEY SPEAK, IS SORE AND STINGS IF THEY PUT ANY CREAM ON WHILE THEIR CHIN IS TURNING PURPLE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "89 A ST #100",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "02494",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}