MAUDE Adverse Event Report: B-TEMIA INC KEEOGO - CLINICIAN KIT

Model Number	5062601
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Chest Pain (1776); Pain (1994)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The keeogo dermoskeleton involved in this event was inspected on site by the clinical team and confirmed to be functioning properly before, during, and after the incident.No device malfunction, defect, or abnormal behavior was identified.The adverse event was reported to the french competent authority (ansm) on 2025-09-18 by the manufacturer (b-temia) in accordance with eu mdr requirements.At this stage, no remedial action or field safety corrective action was initiated.The patient remains hospitalized in stable condition.B-temia will submit a supplemental mdr once additional clinical information becomes available from the investigational site (e.G., patient cardiovascular history, concomitant medications, baseline vital signs).
Event or Problem Description
On (b)(6) 2025, during the exhomesep clinical investigation in france (protocol id-(b)(4)), a 74-year-old male subject (patient id: (b)(6) with a pre-existing diagnosis of primary progressive multiple sclerosis experienced acute cardiac symptoms while performing a supervised rehabilitation exercise session with the keeogo dermoskeleton system.At 15:00, the subject developed retrosternal constrictive chest pain radiating to the jaw and left arm during the session.Symptoms resolved after stopping the exercise.At 20:00, chest pain recurred at rest for about one hour, with blood pressure measured at 180 mmhg.Ecg was inconclusive.Troponin later tested positive (increase from 10 ng/l to 35 ng/l).On (b)(6) 2025 at 02:00, chest pain recurred again, requiring admission to the cardiology department for suspected angina/nstemi.The event was classified as life-threatening.The patient remained hospitalized in stable condition at the time of reporting.The keeogo device was inspected by the study team and confirmed to be functioning properly before, during, and after the incident, with no defect or malfunction identified.The investigator noted the possibility that the physical effort required while using the device during exercise may have contributed to the event.Ecg: t wave inversion in lead t and avl; slight st depression in v4-v5.Biological results: potassium 3.5 mmol/l; creatinine 68 [?]mol/l; egfr 90 ml/min; troponin 12 ng/l then 35 ng/l; wbc 6 g/l; hemoglobin 14.5 g/dl; platelets 220 g/l.Echocardiography: severe hypokinesia of the mid-to-distal inferolateral wall, extending laterally; findings compatible with myocardial ischemia.Clinical assessment: cardiopulmonary exam without signs of heart failure.Date of cardiology admission: (b)(6) 2025.Pre-existing condition: primary progressive multiple sclerosis (ppms).No known cardiovascular history prior to the event.Risk factors: age, male sex, sedentary lifestyle, history of smoking cessation, family history (father had myocardial infarction before age 50).No concomitant medications reported.Concomitant therapy: supervised physical rehabilitation in center (started (b)(6) 2025).
Additional Manufacturer Narrative
The keeogo dermoskeleton involved in this event was inspected on site by the clinical team and confirmed to be functioning properly before, during, and after the incident.No device malfunction, defect, or abnormal behavior was identified.The adverse event was reported to the french competent authority (ansm) on 2025-09-18 by the manufacturer (b-temia) in accordance with eu mdr requirements.At this stage, no remedial action or field safety corrective action was initiated.The patient remains hospitalized in stable condition.B-temia will submit a supplemental mdr once additional clinical information becomes available from the investigational site (e.G., patient cardiovascular history, concomitant medications, baseline vital signs).Follow-up information: the adverse event was also reported to the ansm on 2025-09-05 by the sponsor.The event was declared to the manufacturer on 2025-09-08 (fu1).The patient underwent two coronary angioplasty procedures with stent implantation on (b)(6) 2025 (second marginal artery) and (b)(6) 2025 (mid right coronary artery).He was discharged home on (b)(6) 2025 with appropriate cardiovascular pharmacotherapy.The research procedure was definitively discontinued.The subject was withdrawn from the study (fu1).The investigator and the sponsor assessed the relationship with the research procedures as probable.The investigator assessed the relationship with the investigational device as probable.The sponsor assessed the relationship with the device as without relation.Peak troponin reached 342 ng/l.A major dyslipidemia was identified (ldl cholesterol 2.43 g/l) (fu1).On (b)(6) 2025, the patient was reassessed by the principal investigator.Clinical status remained unchanged since discharge.The subject was not yet recovered.Clinical evolution was assessed as improvement (fu2).On (b)(6) 2025, clinical status remained unchanged.A cardiopulmonary exercise test ((b)(6) 2025) revealed a mild alteration of aerobic capacity, predominantly peripheral, with no cardiological risk criteria.Progressive resumption of activities was considered possible.A rehabilitation and exercise reconditioning program was planned for late (b)(6) 2025.The subject was not yet recovered as of (b)(6) 2025.Clinical evolution was assessed as improvement (fu3).The patient underwent an inpatient rehabilitation and exercise reconditioning program from (b)(6) 2025 to (b)(6) 2025, including gait retraining.The event was assessed as resolved on (b)(6) 2025, with sequelae consisting of a coronary stent.Hospitalization periods: (b)(6) 2025 to (b)(6) 2025 (cardiology department), (b)(6) 2025 to (b)(6) 2025 (rehabilitation and exercise reconditioning).Walking tests were performed on (b)(6) 2026.The relationship assessments with the research procedures (probable per investigator and sponsor) and with the device (probable per investigator, without relation per sponsor) remain unchanged (fu4).At this stage, no remedial action or field safety corrective action has been initiated.
Event or Problem Description
On (b)(6) 2025, during the exhomesep clinical investigation in france (protocol id-(b)(4), a 74-year-old male subject (patient id: (b)(6)) with a pre-existing diagnosis of primary progressive multiple sclerosis experienced acute cardiac symptoms while performing a supervised rehabilitation exercise session with the keeogo dermoskeleton system.At 15:00, the subject developed retrosternal constrictive chest pain radiating to the jaw and left arm during the session.Symptoms resolved after stopping the exercise.At 20:00, chest pain recurred at rest for about one hour, with blood pressure measured at 180 mmhg.Ecg was inconclusive.Troponin later tested positive (increase from 10 ng/l to 35 ng/l).On (b)(6) 2025 at 02:00, chest pain recurred again, requiring admission to the cardiology department for suspected angina/nstemi.The event was classified as life-threatening.On (b)(6) 2025, an acute sub-occlusive stenosis at the ostium of the second marginal artery was identified and treated by angioplasty with stent implantation (fu1).On (b)(6) 2025, a second angioplasty was performed with stent implantation in the mid right coronary artery for a significant ulcerated stenosis; procedure was uneventful (fu1).On (b)(6) 2025, the patient was discharged home (fu1).On (b)(6) 2025, the patient was reassessed by the principal investigator.Clinical status remained unchanged since discharge on (b)(6) 2025 (fu2).On (b)(6) 2025, clinical status remained unchanged.Progressive resumption of previous activities was considered possible.A rehabilitation and exercise reconditioning program was planned for late (b)(6) 2025 (fu3).The patient underwent an inpatient rehabilitation and exercise reconditioning program from (b)(6) 2025 to (b)(6) 2025, including gait retraining.Walking tests were performed on (b)(6) 2026 (fu4).The keeogo device was inspected by the study team and confirmed to be functioning properly before, during, and after the incident, with no defect or malfunction identified.The investigator noted the possibility that the physical effort required while using the device during exercise may have contributed to the event.The subject was withdrawn from the study following this event.The research procedure was definitively discontinued as of (b)(6) 2025 (fu1).

• Brand Name: KEEOGO - CLINICIAN KIT
• Common Device Name: KEEOGO - CLINICIAN KIT
• Manufacturer (Section D): B-TEMIA INC; 4780 rue st-félix, unit 105; st-augustin-de-desmaures, québec G3A 2 J9; CA G3A 2J9
• Manufacturer (Section G): B-TEMIA INC.; 4780, rue st-felix - unite 105; st-augustin-de-desmaures, quebec G3A2J 9; CA G3A2J9
• Manufacturer Contact: alexandre jokic ; 4780 str. st-felix, unit 105; st-augustin-de-desmaures; st-augustin-de-desmaures, quebec G3A 2-J9 ; CA G3A 2J9
• MDR Report Key: 23086519
• Report Number: 3011819880-2025-12200
• Device Sequence Number: 21253351
• Product Code: PHL
• UDI-Device Identifier: 07540162060007
• UDI-Public: 07540162060007
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201539
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5062601
• Device Catalogue Number: 5062601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO CONCOMITANT MEDICATIONS REPORTED BY SITE.; PHYSICAL REHAB THERAPY (SUPERVISED SESSION).
• Outcome Attributed to Adverse Event: Hospitalization; Other; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic