BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZONA PLUS

    MDR report key: 3030646 · Received March 25, 2013

    Report

    Report Number
    3005404127-2013-00001
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ZONA HEALTH
    Product Code
    BXB
    PMA / PMN Number
    K974416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED BACK FOR EVALUATION ON (B)(4) 2013. COMPLETED EVALUATION ON (B)(4) 2013. FINDINGS: THE DEVICE WAS CLEAN WITH NO COSMETIC DEFECT OR DAMAGE. THERE WERE NO SIGNS OF WEAR OR EXCESSIVE USE. ISOMETRIC EXERCISE THERAPY PROTOCOL FUNCTIONS ACCORDING TO SPECIFICATIONS. ISOMETRIC EXERCISE SQUEEZE FORCE IS WITHIN EXPECTED TOLERANCES. DEVICE SQUEEZE FORCE SENSOR RESPONDED IN A LINEAR FASHION AND ISOMETRIC EXERCISE SQUEEZE FORCE LEVELS WERE WITHIN SPECIFICATIONS. THE DEVICE PASSED ALL INITIAL FUNCTION CHECKS AND INSPECTIONS AND CALIBRATION PERFORMANCE WAS AS EXPECTED. CONCLUSION: THE DEVICE WAS WITHIN ALL SPECIFICATIONS AND THERE IS NO INDICATION OF A DEVICE DESIGN, MANUFACTURING OR QUALITY ISSUE ASSOCIATED WITH THE CONSUMER'S SYMPTOMS. DEVICE LABELING WARNS SUBJECTS TO CONSULT THEIR DOCTOR PRIOR TO BEGINNING THE ZONA PLUS ISOMETRIC EXERCISE PROGRAM, BUT CONSUMER REPORTED HE DID NOT DO SO. DEVICE IS HAND-GRIP THERAPY DEVICE ORIGINALLY SUBMITTED IN K974416 BUT ULTIMATELY FOUND TO BE 510(K) EXEMPT.

    Description of Event or Problem · 1

    A CONSUMER INITIALLY CONTACTED THE COMPANY ON (B)(6) 2013 REQUESTING A REFUND FOR HIS ZONA PLUS DEVICE. HE STATED THAT HE WOULD NOT BE NEEDING THE DEVICE ANYMORE BECAUSE HE HAD EXPERIENCED A HEART ATTACK. ADDITIONAL FOLLOW-UP WITH THE CUSTOMER ON (B)(4) 2013 SHOWED THAT THE CUSTOMER HAD BEEN USING THE DEVICE FOR ABOUT 2 MONTHS, AND HAD BEEN USING IT A MINIMUM OF 5 DAYS PER WEEK AS PER THE INSTRUCTIONS FOR USE. HE STOPPED USING THE DEVICE ON (B)(6) 2013 ON THE ADVICE OF HIS PHYSICIAN AFTER EXPERIENCING A HEART ATTACK. HE HAD NEVER TOLD HIS PHYSICIAN HE WAS USING IT UNTIL THE DAY OF THE HEART ATTACK AND HAD NOT EXPERIENCING ANY SYMPTOMS OF THE HEART ATTACK UNTIL THE DAY OF THE ATTACK. HE REPORTED THAT HE HAD NO SYMPTOMS WHILE USING THE DEVICE AND HAD NOT USED IT SINCE THE PRIOR DAY AT THE TIME OF HIS HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121513 ZONA PLUS PROD CODE BXB: HANDGRIP EXERCISE DEVICE BXB ZONA HEALTH ZONA PLUS V2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening THE CONSUMER ALSO REPORTED THAT HE WAS ON MOBIC| A NON STEROIDAL ANTI-INFLAMMATORY AT THE TIME OF| THE HEART ATTACK