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

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.

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.

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.Updated information in section h10 after further investigation by manufacturer: a postage paid label was sent to retrieve the unit for further investigation.Consumer did not return the unit back.The manufacturer reviewed the qa test data/shipping inspection data and complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.The risk analysis document was reviewed and similar risk has been analyzed.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

• Brand Name: OMRON ELECTROTHERAPY PAIN RELIEF
• Type of Device: TRANSCUTANEOUS 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 Key: 11614535
• MDR Text Key: 243794767
• Report Number: 1450057-2021-00005
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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 Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PM3030
• Device Catalogue Number: PM3030
• Device Lot Number: 201608UF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2021
• Distributor Facility Aware Date: 03/25/2021
• Device Age: 55 MO
• Event Location: Home
• Date Report to Manufacturer: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability