MAUDE Adverse Event Report: B-TEMIA INC. KEEOGO - CLINICIAN KIT; KEEOGO DERMOSKELETON SYSTEM

Model Number	5062601
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, during the exhomesep clinical investigation in france (protocol id-rcb 2021-a03094-37), 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: on (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 on (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).

• Brand Name: KEEOGO - CLINICIAN KIT
• Common Device Name: KEEOGO DERMOSKELETON SYSTEM
• Manufacturer (Section D): B-TEMIA INC.; 4780, rue st-félix - unité 105; st-augustin-de-desmaures, quebec G3A2J 9; CA G3A2J9
• 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 rue st-félix, unité 105; st-augustin-de-desmaures; québec, G3A 2-J9 ; CA G3A 2J9
• MDR Report Key: 23085338
• Report Number: 3011819880-2025-00122
• Device Sequence Number: 15901664
• 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
• Report Date (Section B): 09/18/2025

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
• Initial Report FDA Received Date: 09/18/2025
• 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: Other; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic