BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POCKET PAIN PRO TENS UNIT

    MDR report key: 19283013 · Received May 9, 2024

    Report

    Report Number
    8030245-2024-00002
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 23, 2024
    Report Date
    August 16, 2024
    Manufacturer
    OMRON HEALTHCARE CO., LTD
    Product Code
    NUH
    UDI-DI
    00073796634001
    PMA / PMN Number
    K181992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A ROOT CAUSE HAS NOT BEEN DETERMINED. IT HAS NOT BEEN CONFIRMED IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT; HOWEVER, DUE TO THE CUSTOMER REPORTING HAVING BURNS THIS MEDWATCH IS BEING FILED. THE CONSUMER WAS OFFERED A REFUND. THE PRODUCT INSTRUCTION MANUAL INCLUDES FOLLOWING WARNINGS: THE MERE EXISTENCE OF PAIN FUNCTIONS AS A VERY IMPORTANT WARNING TELLING US THAT SOMETHING IS WRONG. THEREFORE, IF YOU SUFFER FROM ANY SERIOUS ILLNESS, CONSULT YOUR PHYSICIAN IN ORDER TO CONFIRM THAT IT IS ADVISABLE FOR YOU TO USE THIS UNIT. IF YOU EXPERIENCE ANY SKIN IRRITATION OR REDNESS AFTER A SESSION, DO NOT CONTINUE STIMULATION IN THAT AREA OF THE SKIN. PLACE PADS ON EITHER SIDE OF THE PAIN, NOT DIRECTLY ON THE PAIN. POSSIBLE ADVERSE REACTIONS: YOU SHOULD STOP USING THE UNIT AND CONSULT WITH YOUR PHYSICIAN IF YOU EXPERIENCE ADVERSE REACTIONS FROM THE UNIT. YOU MAY EXPERIENCE SKIN IRRITATION AND BURNS BENEATH THE STIMULATION ELECTRODES APPLIED TO YOUR SKIN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE UPDATED INFORMATION SECTION B4. ADDITIONAL INFORMATION ADDED TO SECTION G6, H2, H3, H6, H10, AND H11. THE DEVICE WAS NOT RETURNED TO THE DISTRIBUTOR/MANUFACTURER FOR INVESTIGATION AND THE INVESTIGATION WAS CLOSED ON 7/25/2024. HERE IS THE SUMMARY OF THE MANUFACTURER DEVICE INVESTIGATION: THE MANUFACTURER REVIEWED THE QA TEST DATA, RISK ANALYSIS DOCUMENT AND MANUFACTURER SHIPPING INSPECTION. NO ISSUE/PROBLEM WAS NOTED BASED ON THE DATA REVIEWED. THERE WAS ONE SIMILAR EVENT REPORTED FOR THE SAME MODEL IN THE PAST. HOWEVER, NO ABNORMAL TREND WAS IDENTIFIED FOR SIMILAR MODELS POST MARKET. THE UNIT WAS NOT RETURNED BY CONSUMER. THERE HAS NOT BEEN ANY ADDITIONAL COMMUNICATION FROM THIS CONSUMER. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 0

    THE CONSUMER SENT AN EMAIL STATING THAT HE PURCHASED A TENS UNIT FROM A CVS IN PHOENIX, AZ. HE USED THE UNIT ONCE AS INSTRUCTED AND WAS TOLD BY THE (B)(6) HOSPITAL THAT HE RECEIVED SECOND DEGREE BURNS. DURING A FOLLOW-UP CALL, THE CONSUMER STATED HIS WIFE BOUGHT THE UNIT FOR HIS BURSITIS. HE STATED IT WAS AMAZING WHAT IT DID WHEN HE FIRST USED THE UNIT FOR HIS BURSITIS. HE STATED THAT AFTER A WHILE HE REMOVED THE UNIT AND HE SAW A BURN SO HE WENT TO THE (B)(6) HOSPITAL, AND THEY GAVE HIM MEDICINE FOR A SECOND DEGREE BURN. HE STATED HE WAS VERY EXCITED ABOUT THE UNIT BUT HESITANT TO USE IT AGAIN. HE STATED HE WAS WALKING OR SITTING DOWN WHEN THE BURN HAPPENED. HE WAS WEARING STRETCHY PANTS OVER THEM LIKE SWEATPANTS. THE PADS WERE PLACED 6-7 INCHES APART FROM ONE ANOTHER. THERE WERE NO OTHER DEVICES NEARBY. HE STATED HE USED THE UNIT FOR ONE ROUND OF 15 MINUTES. HE WAS THE ONLY USER. HE STATED THE EVENT TOOK PLACE ON APRIL 23RD AROUND 5-6 PM. HE WENT TO THE (B)(6) HOSPITAL ON (B)(6). HE WAS USING THE ORIGINAL PADS. HE STATED THE BURN WAS ON HIS RIGHT HIP AND BUTTOCKS RIGHT WHERE THE HIP BONES MEET. HE STATED HE WAS NOT ALLERGIC TO ANYTHING, BUT HE REMEMBERS WHEN HE WAS YOUNG THAT INNER TUBES WOULD IRRITATE HIS SKIN. HE STATED HE HAD SENSITIVE SKIN. HE STATED HE USED THE UNIT AFTER SHOWERING AND USING BODY WASH. HE MADE SURE THE AREA WAS DRY. HE PEELED OFF THE LABEL AND USED BOTH PADS, AND THERE WAS NO OIL OR LOTION ON THE SKIN. HE WAS PRESCRIBED OINTMENT TO PUT ON THE BURN AND HAD NO OTHER TREATMENTS DONE DURING THE VISIT. HE STATED HE WAS GETTING A SHOT OF CORTISONE FOR HIS BURSITIS INSTEAD. HE AGREED TO SEND THE UNIT BACK FOR INSPECTION AND REQUESTED A REFUND. THE CONSUMER CALLED BACK ON MAY 1ST, 2024 TO SPEAK TO THE CALL CENTER REPRESENTATIVE. SHE WAS UNAVAILABLE AT THE TIME SO HE HUNG UP. SHE CALLED BACK, BUT HE DID NOT ANSWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122568 POCKET PAIN PRO TENS UNIT TENS NUH OMRON HEALTHCARE CO., LTD PM400 202308V 00073796634001

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Other