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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 2) OMRON ELECTROTHERAPY PAIN RELIEF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR T.E.N.S,

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OMRON (DALIAN) CO., LTD. (PLANT 2) OMRON ELECTROTHERAPY PAIN RELIEF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR T.E.N.S, Back to Search Results
Model Number PM3030
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 01/25/2021
Event Type  Injury  
Manufacturer Narrative
A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made. 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 pain that is constant and is affecting his walking and sleeping and getting prescribed muscle relaxant this medwatch is being filed. The product instruction manual includes following warnings: if you have had medical or physical treatment for your pain, consult with your physician before using this device. If your pain does not improve, becomes seriously chronic or severe, or continues for more than five days, stop using the device and consult with your physician. 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 electrotherapy unit. The u. S importer is requesting the manufacturer of the device to further investigate this incident.
 
Event Description
Consumer called and reported that unit is giving him pain on his hip and thigh. He has used the unit in other parts of body and did fine (no issue). He can only use the unit on his hip and thigh for 10 minutes before the unit starts to hurt him. He did go to the doctor and the doctor gave him muscle relaxer for the pain about a month ago and that did not really help him. He is the only user of the unit. All this happened about two month ago. He is unable to lay on his side at night to sleep due the pain. Consumer stated the skin is dry and clean in the area of the pads. He cleans the pads at least once a week and places the pads about 4" part. He is using duracell high efficacy batteries with the unit. Consumer was sent a postage paid label via email to retrieve the unit for testing. During follow-up call, consumer stated he used the product on his back, knee, and sciatica and never had any issues. He started using it on his hip and it stated to cause him pain. He placed the pads exactly the way they were placed on the diagram. He follows instructions in the manual very carefully. He tried it on the hip one time, had it on for 5 minutes, and took it off because of the pain. Per consumer, it was 2 months ago, that he got the pain and it is still present. He has not used it on his hip since then but has used it in the other locations no issues. The pain is constant and is affecting his walking and sleeping. He is used to walking 3 miles a day and since this happened he cannot walk more than 10 minutes without the pain becoming very intense. He cannot sleep on his right hip because of the pain is so intense. He did see his doctor regarding the pain and he was prescribed muscle relaxant. That did not relieve pain though and that was about one month ago. The pain is throbbing, aching, and constant. Consumer stated he does try to lay on the right side and it is a burning piercing pain. He has not been back to doctor for follow-up yet. The doctor's appointments are like curbside pickups right now and all they will do is prescribe more medication and if one did not help why would another. He has tried to use heat and ice to relieve pain and that does not help either. Consumer stated he does have a friend that is a doctor and a malpractice attorney and he is going to check with him and see why he had this reaction on his hip but the unit works fine everywhere else on his body that he has tried it. Consumer requested that omron sends him a new tens unit. Omron representative sent him a new unit and sent a postage paid label to retrieve his unit for further investigation.
 
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Brand NameOMRON ELECTROTHERAPY PAIN RELIEF
Type of DeviceTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR T.E.N.S,
Manufacturer (Section D)
OMRON (DALIAN) CO., LTD. (PLANT 2)
no. 28 dongbei er street, eco-
nomic & technical development
dalian liaoning, 11660 0
CH 116600
MDR Report Key11614535
MDR Text Key243794767
Report Number1450057-2021-00005
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPM3030
Device Catalogue NumberPM3030
Device Lot Number201608UF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2021
Distributor Facility Aware Date03/25/2021
Device Age55 MO
Event Location Home
Date Report to Manufacturer04/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
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