{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 17364 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "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": "Malfunction", "report_number": "2381757-2020-00350", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K141294", "date_of_event": "20200328", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464776", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB", "generic_name": "TAMPON, MENSTRUAL, UNSCENTED", "manufacturer_d_name": "KIMBERLY-CLARK CORPORATION - CONWAY MILL", "manufacturer_d_address_1": "480 EXCHANGE AVE.", "manufacturer_d_address_2": "", "manufacturer_d_city": "CONWAY", "manufacturer_d_state": "AR", "manufacturer_d_zip_code": "72032", "manufacturer_d_zip_code_ext": "7191", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "720327191", "device_operator": "LAY USER/PATIENT", "model_number": "SUPER PLUS", "catalog_number": "", "lot_number": "AC907624X0149", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HEB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00036000998443", "udi_public": "00036000998443", "openfda": { "device_name": "Tampon, Menstrual, Unscented", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.5470", "device_class": "2" } } ], "product_problems": [ "Product Quality Problem", "Sharp Edges", "Product Quality Problem", "Sharp Edges" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/28/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250821", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "32 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cyst(s)", "Fever", "Unspecified Infection", "Pain", "Burning Sensation", "Wound Infection", "Ambulation or Postural Difficulties", "Cyst(s)", "Fever", "Unspecified Infection", "Pain", "Burning Sensation", "Wound Infection", "Ambulation or Postural Difficulties" ] } ], "distributor_city": "", "date_report": "20200527", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001206", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200331", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "311603916", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: THIS IS A FOLLOW UP TO REPORT THAT CONSUMER WENT TO THE DOCTOR AND HAD DIAGNOSTIC LABORATORY TESTS, PAP, AND ULTRASOUND. SHE HAD TWO CUTS FROM THE APPLICATOR, AN EXTERNAL VAGINAL CUT AND INTERNAL VAGINAL CUT. THE EXTERNAL CUT BECAME INFECTED AND A CYST DEVELOPED. SHE EXPERIENCED FEVER AND PAIN DUE TO THE INFECTION, DIFFICULTY WALKING AND WAS UNABLE TO WORK. THE INFECTION ALSO CAUSED A BURNING SENSATION WHEN URINATING. SHE WAS PRESCRIBED UNSPECIFIED ANTIBIOTICS FOR THE INFECTION. CONSUMER ALLEGED THE TAMPON HAD EXTRA PLASTIC ON IT, LIKE SHARDS, AND THIS CAUSED THE CUTS. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION ON CONSUMER'S OUTCOME, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." }, { "mdr_text_key": "311603917", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS IS A FOLLOW UP TO REPORT THAT CONSUMER WENT TO THE DOCTOR AND HAD DIAGNOSTIC LABORATORY TESTS, PAP, AND ULTRASOUND. SHE HAD TWO CUTS FROM THE APPLICATOR, AN EXTERNAL VAGINAL CUT AND INTERNAL VAGINAL CUT. THE EXTERNAL CUT BECAME INFECTED AND A CYST DEVELOPED. SHE EXPERIENCED FEVER AND PAIN DUE TO THE INFECTION, DIFFICULTY WALKING AND WAS UNABLE TO WORK. THE INFECTION ALSO CAUSED A BURNING SENSATION WHEN URINATING. SHE WAS PRESCRIBED UNSPECIFIED ANTIBIOTICS FOR THE INFECTION. CONSUMER ALLEGED THE TAMPON HAD EXTRA PLASTIC ON IT, LIKE SHARDS, AND THIS CAUSED THE CUTS. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION ON CONSUMER'S OUTCOME, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." }, { "mdr_text_key": "189334309", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION." }, { "mdr_text_key": "189334310", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CONSUMER EXPERIENCED A SHARP PAIN UPON INSERTION OF THE TAMPON. FOLLOWING INSERTION, THE CONSUMER NOTED THE APPLICATOR PETALS WERE OPEN AND JAGGED, CUTTING HER RIGHT LABIA CAUSING A BLEEDING PUNCTURE TYPE WOUND. THE CONSUMER'S SPOUSE WAS A CERTIFIED NURSE ASSISTANT AND TREATED THE WOUND WITH AN UNSPECIFIED TOPICAL OTC MEDICATION. IN A FOLLOW UP WITH THE CONSUMER, THE WOUND HAD ALLEGEDLY BECOME INFECTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION ABOUT CONSUMER'S OUTCOME, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED." } ], "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": "05/27/2020" } ] }