BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFLOVEST

    MDR report key: 19398331 · Received May 25, 2024

    Report

    Report Number
    3004183730-2024-00002
    Event Type
    Injury
    Date Received
    May 25, 2024
    Date of Event
    January 4, 2024
    Report Date
    May 24, 2024
    Manufacturer
    TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL
    Product Code
    BYI
    UDI-DI
    00816305024005
    PMA / PMN Number
    K122480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED PRODUCT EVALUATION SUMMARY: RETURNED SMALL VEST SERIAL # (B)(6), BATTERY, POWER SUPPLY AND DUFFLE BAG. BATTERY HAS 5 BARS ON THE FUEL GAUGE, MEASURED 16.71 VOLTS ON THE MULTIMETER. TESTED BATTERY ON UBA5 BATTERY ANALYZER. BATTERY PASSED. POWER SUPPLY MEASURED 18.00 VOLTS ON THE MULTIMETER. VEST HAS 129 HOURS AND 37 MINUTES RUN TIME. VEST PASSED MOTOR SEQUENCE TEST. RAN THERAPY THAT WAS SAVED UPON RECEIPT OF VEST. ALL TREATMENTS FUNCTIONAL AND WORKED AS THEY SHOULD WITH NO ISSUES.

    Description of Event or Problem · 0

    ON JANUARY 4, 2024, THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT BY HIS PARENTS BECAUSE HE HAD BEEN SICK. UPON EXAMINATION, INCLUDING X-RAYS, IT WAS DISCOVERED THE PATIENT HAD MULTIPLE RIB FRACTURES THOUGH NO CAUSE WAS IDENTIFIED. DURING A FOLLOW APPOINTMENT WITH HIS PRIMARY CARE PHYSICIAN (PCP) ON JANUARY 23, 2024, THE PCP ASSESSMENT NOTED THE PATIENT'S SIGNIFICANT HISTORY OF CEREBRAL PALSY AND LIMITED MOBILITY INDICATING THAT COULD LEAD TO BRITTLE BONES AND THAT REGULAR USE OF A PERCUSSIVE DEVICE MAY HAVE CONTRIBUTED TO THE FRACTURED RIBS. INVESTIGATION OF THE RIB FRACTURES WITH DEXA SCAN AND DISCONTINUATION OF USE OF THE PERCUSSIVE DEVICE WERE ALSO DISCUSSED AT THIS APPOINTMENT. USE OF THE DEVICE WAS DISCONTINUED AND PRODUCT WAS RETURNED TO THE DISTRIBUTOR THAT PROVIDED THE PRODUCT TO THE PATIENT. ON APRIL 16, 2024, DURING THE PROCESS OF RETURNING THE PRODUCT THE PARENT INFORMED THE DISTRIBUTOR OF THE EVENT. THE DISTRIBUTOR NOTIFIED MANUFACTURER, TACTILE MEDICAL, ON APRIL 26, 2024. USE OF THE DEVICE WAS DISCONTINUED AND PRODUCT WAS RETURNED. TACTILE MEDICAL HAS RECEIVED NO INDICATION OF ANY FURTHER MEDICAL EVALUATIONS RELATING TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299802 AFFLOVEST PERCUSSOR, POWERED-ELECTRIC BYI TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL 8100 00816305024005

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other