BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL THERAPIST

    MDR report key: 24976697 · Received April 24, 2026

    Report

    Report Number
    3012900326-2026-00001
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 21, 2026
    Manufacturer
    SWORD HEALTH S.A.
    Product Code
    ISD
    UDI-DI
    05065013876009
    PMA / PMN Number
    510(K)EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED A REPORT OF A STRESS FRACTURE IN THE RIGHT FOOT, CONFIRMED BY X-RAY FROM ON (B)(6) 2026, DESCRIBED AS BEING IN A HEALING PHASE. ON (B)(6) 2026, THE MEMBER REPORTED THIS FINDING TO THE ASSIGNED PHYSICAL THERAPIST AND ATTRIBUTED THE CONDITION TO PARTICIPATION IN THE DIGITAL THERAPIST-GUIDED THERAPY PROGRAM INITIATED ON (B)(6) 2026. THE MEMBER REPORTED ONSET OF RIGHT FOOT SWELLING SHORTLY AFTER STARTING THE PROGRAM, WHICH PERSISTED OVER TIME. A TOTAL OF 13 THERAPY SESSIONS WERE COMPLETED BETWEEN ON (B)(6) 2026 (LAST COMPLETED SESSION ON (B)(6) 2026). THE MEMBER REPORTED RIGHT FOOT SWELLING ON (B)(6) 2026, WHICH WAS FOLLOWED UP BY THE ASSIGNED PHYSICAL THERAPIST. THE MEMBER CONTINUED PARTICIPATION IN THE PROGRAM AFTER THIS REPORT. THE MEMBER HAS A COMPLEX MEDICAL HISTORY, INCLUDING BILATERAL FLAT FEET, PARTIALLY TORN POSTERIOR TIBIAL LIGAMENTS, ADVANCED ARTHRITIS IN BOTH FEET, TARSAL TUNNEL SYNDROME, CHRONIC ANKLE PAIN, BILATERAL GLUTEUS MEDIUS AND MINIMUS TENDON TEARS, AND PRIOR TRAUMATIC INJURIES INCLUDING MULTIPLE FRACTURES AND A SPINAL CORD INJURY. THE MEMBER USES ASSISTIVE DEVICES (WALKER AT HOME AND CANE IN THE COMMUNITY) AND REPORTS LIMITATIONS WITH AMBULATION AND WEIGHT-BEARING ACTIVITIES. THESE CONDITIONS MAY AFFECT LOWER EXTREMITY LOAD TOLERANCE. THE MANUFACTURER CONDUCTED AN INVESTIGATION THAT INCLUDED REVIEW OF THE MEMBER'S REPORTED INFORMATION, PHYSICAL THERAPIST DOCUMENTATION, FOLLOW-UP ATTEMPTS, AND DEVICE USAGE DATA. RECORDS INDICATE THAT THE THERAPY PROGRAM WAS MODIFIED MULTIPLE TIMES IN RESPONSE TO REPORTED SYMPTOMS. THERE IS NO INFORMATION INDICATING THAT THE MEMBER EXCEEDED THE PRESCRIBED PROGRAM. NO DEVICE MALFUNCTION OR PERFORMANCE ISSUE WAS IDENTIFIED DURING THE INVESTIGATION. THE MEMBER REPORTED A POTENTIAL SYSTEM-RELATED CONCERN ON (B)(6) 2026 RELATED TO A SPECIFIC EXERCISE (HAMSTRING STRETCH); HOWEVER, NO ASSOCIATED CLINICAL IMPACT WAS REPORTED, AND NO RECURRENCE OF THE ISSUE WAS DOCUMENTED FOLLOWING PHYSICAL THERAPIST FOLLOW-UP. COMMUNICATION WITH THE MEMBER WAS LIMITED DUE TO LACK OF RESPONSE TO FOLLOW-UP ATTEMPTS, WHICH LIMITED FURTHER CLINICAL ASSESSMENT. BASED ON THE AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED STRESS FRACTURE COULD NOT BE ESTABLISHED. THE PHYSICAL THERAPIST ATTEMPTED FOLLOW-UP WITH THE MEMBER, AND THE THERAPY PROGRAM WAS ADJUSTED AND SUBSEQUENTLY PLACED ON HOLD FOLLOWING THE REPORT OF THE EVENT. THE MANUFACTURER IS EVALUATING THIS EVENT WITHIN ITS RISK MANAGEMENT PROCESS.

    Description of Event or Problem · 0

    THE MEMBER REPORTED THAT AFTER INITIATING USE OF THE DIGITAL THERAPIST PROGRAM ON (B)(6) 2026, THEY EXPERIENCED SWELLING IN THE RIGHT FOOT WITHIN THE FIRST FEW DAYS OF PERFORMING THE PRESCRIBED EXERCISES. THE MEMBER COMPLETED A TOTAL OF 13 SESSIONS, WITH THE LAST SESSION PERFORMED ON (B)(6) 2026. THE MEMBER REPORTED RECEIVING AN X-RAY EVALUATION FROM ON (B)(6) INDICATING A STRESS FRACTURE OF THE RIGHT FOOT DESCRIBED AS BEING IN A HEALING PHASE. THE MEMBER ATTRIBUTED THE FRACTURE TO THE EXERCISES PERFORMED DURING THE INITIAL PHASE OF THE PROGRAM. THEY STATED THAT SWELLING BEGAN AFTER STARTING THE PROGRAM AND PERSISTED. THE MEMBER ALSO REPORTED THAT THEY WERE UNABLE TO PERFORM SOME MOVEMENTS DUE TO PRE-EXISTING LIMITATIONS. THE MEMBER INDICATED THAT THEY ENGAGE IN ADDITIONAL REGULAR PHYSICAL ACTIVITY, INCLUDING DAILY POOL-BASED EXERCISE AND WEEKLY SESSIONS WITH A GYM TRAINER. THE PHYSICAL THERAPIST ATTEMPTED TO FOLLOW UP WITH THE MEMBER TO ASSESS SYMPTOMS AND SCHEDULE A CALL; HOWEVER, COMMUNICATION WAS INCONSISTENT AND MULTIPLE OUTREACH ATTEMPTS WERE NOT ANSWERED. FOLLOWING THE REPORT OF THE STRESS FRACTURE, THE THERAPY PROGRAM WAS PLACED ON HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222529 DIGITAL THERAPIST Exerciser, measuring ISD SWORD HEALTH S.A. 05065013876009

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention