{ "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": 145574 } }, "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": "Injury", "report_number": "9616091-2020-00019", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "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": [ "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": "464302", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "TRSX5/WD66/ADULT/28/34P/U240/1255/U2222/BHDRM/9691B/GVT93HC/G1 9153649401", "generic_name": "WHEELCHAIR, MECHANICAL", "manufacturer_d_name": "INVAMEX", "manufacturer_d_address_1": "102 PARQUE INDUSTRIAL MANIMEX", "manufacturer_d_address_2": "", "manufacturer_d_city": "REYNOSA, TAMAULIPAS", "manufacturer_d_state": "", "manufacturer_d_zip_code": "88780", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "MX", "manufacturer_d_postal_code": "88780", "device_operator": "LAY USER/PATIENT", "model_number": "NA:GVTRSX56", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "IOR", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "9616091" ], "fei_number": [ "1000253203" ], "device_name": "Wheelchair, Mechanical", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3850", "device_class": "1" } } ], "product_problems": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250728", "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": [ "Required Intervention" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "91", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bone Fracture(s)", "Bone Fracture(s)" ] } ], "distributor_city": "", "date_report": "20200421", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001048", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200421", "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": "191855509", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ALLEGATION OF THE TRACER SX5 MANUAL WHEELCHAIR WHEEL LOCKS NOT HOLDING WHEN THE USER BECAME WEAK AND ATTEMPTED TO USE THE CHAIR FOR SUPPORT COULD NOT BE CONFIRMED. THIS IS NOT CONSIDERED A MALFUNCTION OF THE DEVICE. WHEEL LOCKS ARE DESIGNED TO KEEP THE CHAIR IN A STATIONARY POSITION WHILE A USER ENTERS OR EXITS THE CHAIR. THEY ARE NOT INTENDED TO STOP SUBSTANTIAL FORCE APPLIED TO THE CHAIR SUCH AS SOMEONE FALLING ON OR ATTEMPTING TO SUPPORT THEIR FULL BODY WEIGHT. THE MANUAL HAS THE FOLLOWING WARNING REGARDING WHEEL LOCKS: ¿WHEEL LOCKS ARE NOT BRAKES. ENGAGING THE WHEEL LOCKS MAY NOT PREVENT THE WHEELCHAIR FROM MOVING ON ALL FLOOR SURFACES INCLUDING THOSE THAT MAY BE WET OR SLICK.¿ ACCORDING TO THE MANUAL THIS DEVICE HAS A WEIGHT CAPACITY OF 250 POUNDS. BASED ON THE PATIENT WEIGHT PROVIDED THE USER WAS WITHIN THE WEIGHT CAPACITY. THE CALLER STATED HE WAS NOT CAPABLE OF PACKING AND SHIPPING THE DEVICE, THEREFORE IT WILL NOT BE RETURNED FOR AN EVALUATION." }, { "mdr_text_key": "191855510", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE END USER STATED HIS ARMS AND LEGS BECAME WEAK AND HE GRABBED THE TRACER WHEELCHAIR TO TRY AND SUPPORT HIMSELF. HE STATED THE WHEEL LOCKS WERE ENGAGED BUT THEY DIDN¿T HOLD, AND THE CHAIR MOVED BACKWARD, AND HE FELL ON THE CHAIR AND BROKE HIS WRIST. HE STATED A DOCTOR TOOK X-RAYS AND PLACED A CAST ON HIS LEFT WRIST. HE STATED THE CHAIR HAD NO ISSUES PRIOR TO THE INCIDENT OCCURRING. HE STATED THE CHAIR IS NOW BROKEN AND IS NO LONGER IN USE." } ], "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": "" } ] }