MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. MAX POWER RELIEF TENS THERAPY UNIT

Model Number	PM500
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 2nd and 3rd degree burns this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A postage label has been sent for retrieval of the home unit for inspection.The consumer was given a refund for the unit.The product instruction manual includes following warnings: possible adverse reactions · do not use to treat one region for extended periods of time (more than 30 minutes a session, up to three times/day) or muscles in that region may become exhausted and sore.Do not leave pads attached to the skin after treatment 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.
Event or Problem Description
The consumer stated the unit has given her 2nd and 3rd degree burns on lower back to the side of her butt crack.She stated she had to go to the er/urgent care on (b)(6) and was told she had an electrical burn.She stated she only used the unit for the 15 minutes required and would turn it back on more than a couple of times (8-10 times) throughout the day.She did not use any creams or other products with the unit.She was lying on her side.She stated she was given burn cream, antibiotics and a tetanus shot due to infection and drainage.During a follow up call, she stated that her tens unit left burn marks on her lower back and posterior and that they are 2nd and 3rd degree burns.She stated that the burns are shaped like pads and are the size of a casaba melon.She stated that she has been off work since (b)(6) 2024.She is a hairdresser.She stated that she is still feeling pain.She went to urgent care per direction of her doctor.She is on antibiotics and burn cream and they also gave her tetanus shot.She needed to change bandages 2-3 times a day.She stated that the unit was set at 9, though sometimes 8.She could feel it and that was the maximum she could tolerate.She stated that she has used omron tens units for years and never had a problem.She bought a new one because her old units are packed up.She stated that she was laying on her side when using the unit and the pads were on her back.She stated that she would use the unit for 15 minutes and then turn the unit back on.She states that she used the unit 8-10 times on that day and the pads were left in place even when unit was turned off.
Additional Manufacturer Narrative
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 2nd and 3rd degree burns this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A postage label has been sent for retrieval of the home unit for inspection.The consumer was given a refund for the unit.The product instruction manual includes following warnings: possible adverse reactions · do not use to treat one region for extended periods of time (more than 30 minutes a session, up to three times/day) or muscles in that region may become exhausted and sore.Do not leave pads attached to the skin after treatment.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.Updated information in section f7.Additional information added to section b5 and h11.After initial report was submitted, the consumer called with additional information that was added to b5.The product instruction manual includes the following in the important safety precautions and warnings section: do not use this unit during these activities when in the bath or shower; while sleeping; while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.
Event or Problem Description
The consumer stated the unit has given her 2nd and 3rd degree burns on lower back to the side of her butt crack.She stated she had to go to the er/urgent care on october 6th and was told she had an electrical burn.She stated she only used the unit for the 15 minutes required and would turn it back on more than a couple of times (8-10 times) throughout the day.She did not use any creams or other products with the unit.She was lying on her side.She stated she was given burn cream, antibiotics and a tetanus shot due to infection and drainage.During a follow up call, she stated that her tens unit left burn marks on her lower back and posterior and that they are 2nd and 3rd degree burns.She stated that the burns are shaped like pads and are the size of a casaba melon.She stated that she has been off work since (b)(6) 2024.She is a hairdresser.She stated that she is still feeling pain.She went to urgent care per direction of her doctor.She is on antibiotics and burn cream and they also gave her tetanus shot.She needed to change bandages 2-3 times a day.She stated that the unit was set at 9, though sometimes 8.She could feel it and that was the maximum she could tolerate.She stated that she has used omron tens units for years and never had a problem.She bought a new one because her old units are packed up.She stated that she was laying on her side when using the unit and the pads were on her back.She stated that she would use the unit for 15 minutes and then turn the unit back on.She states that she used the unit 8-10 times on that day and the pads were left in place even when unit was turned off.The consumer called with additional information on 11/06/24.She stated that she had been badly burnt and been off work since 10/04/24.She stated she really did not want to go to an attorney as she had not been able to stand up and had layers and layers of burns.She did not think she should only get a refund for the unit.She stated she had major burns on her lower end.She stated she was not sending the unit back because she believed a product specialist should look at the unit since she thought it was faulty.She stated she had used products like it in the past and never had this type of burn.She stated she only used the unit once and when she woke up on 10/04/24, she felt the pain and had to pull her pajamas off her skin.She did not know how bad it was and did not want to go to an attorney but she had been off work since it happened.She stated she knew the unit was faulty.She stated she left the pads on when she went to bed and put the cords on her nightstand.She stated she had purple and red scarring on her back and buttocks and had been using burn cream.She stated the hospitals have pictures and that she called an attorney but never did anything.She stated the attorney would need to have the unit.She stated she was a hairdresser and had to switch all of her clients.She stated she was not into attorneys and was looking for omron to do something for her.She stated she needed to get the doctor's opinion on how long it would take for the scar to go away.She stated she received the refund the day prior and never received the return label from omron.She kept stating she did not know what to do and was advised that it was her decision.She was sent the label again to have the unit sent to the inspection center.
Event or Problem Description
The consumer stated the unit has given her 2nd and 3rd degree burns on lower back to the side of her butt crack.She stated she had to go to the er/urgent care on (b)(6) and was told she had an electrical burn.She stated she only used the unit for the 15 minutes required and would turn it back on more than a couple of times (8-10 times) throughout the day.She did not use any creams or other products with the unit.She was lying on her side.She stated she was given burn cream, antibiotics and a tetanus shot due to infection and drainage.During a follow up call, she stated that her tens unit left burn marks on her lower back and posterior and that they are 2nd and 3rd degree burns.She stated that the burns are shaped like pads and are the size of a casaba melon.She stated that she has been off work since (b)(6) 2024.She is a hairdresser.She stated that she is still feeling pain.She went to urgent care per direction of her doctor.She is on antibiotics and burn cream and they also gave her tetanus shot.She needed to change bandages 2-3 times a day.She stated that the unit was set at 9, though sometimes 8.She could feel it and that was the maximum she could tolerate.She stated that she has used omron tens units for years and never had a problem.She bought a new one because her old units are packed up.She stated that she was laying on her side when using the unit and the pads were on her back.She stated that she would use the unit for 15 minutes and then turn the unit back on.She states that she used the unit 8-10 times on that day and the pads were left in place even when unit was turned off.The consumer called with additional information on (b)(6) 2024.She stated that she had been badly burnt and been off work since (b)(6) 2024.She stated she really did not want to go to an attorney as she had not been able to stand up and had layers and layers of burns.She did not think she should only get a refund for the unit.She stated she had major burns on her lower end.She stated she was not sending the unit back because she believed a product specialist should look at the unit since she thought it was faulty.She stated she had used products like it in the past and never had this type of burn.She stated she only used the unit once and when she woke up on (b)(6) 2024, she felt the pain and had to pull her pajamas off her skin.She did not know how bad it was and did not want to go to an attorney but she had been off work since it happened.She stated she knew the unit was faulty.She stated she left the pads on when she went to bed and put the cords on her nightstand.She stated she had purple and red scarring on her back and buttocks and had been using burn cream.She stated the hospitals have pictures and that she called an attorney but never did anything.She stated the attorney would need to have the unit.She stated she was a hairdresser and had to switch all of her clients.She stated she was not into attorneys and was looking for omron to do something for her.She stated she needed to get the doctor's opinion on how long it would take for the scar to go away.She stated she received the refund the day prior and never received the return label from omron.She kept stating she did not know what to do and was advised that it was her decision.She was sent the label again to have the unit sent to the inspection center.
Additional Manufacturer Narrative
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 2nd and 3rd degree burns this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A postage label has been sent for retrieval of the home unit for inspection.The consumer was given a refund for the unit.The product instruction manual includes following warnings: - possible adverse reactions · do not use to treat one region for extended periods of time (more than 30 minutes a session, up to three times/day) or muscles in that region may become exhausted and sore.- do not leave pads attached to the skin after treatment - 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.Updated information in section f7.Additional information added to section b5 and h11.After initial report was submitted, the consumer called with additional information that was added to b5.The product instruction manual includes the following in the important safety precautions and warnings section: do not use this unit during these activities · when in the bath or shower; · while sleeping; · while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.Updated information in section f7.Additional information added to section h11.The device was not returned to the distributor/manufacturer for investigation, and there has not been any additional communication from this consumer.The investigation was closed on 1/15/2025.Here is the summary of the manufacturer device investigation: the manufacturer reviewed the manufacturer shipping inspection.The insepction for the product lot passed.The risk analysis document was reviewed and similar risk has been analyzed.There was one similar event reported for the same model in the past.However, no abnormal trend was identified.Unit was not returned by consumer.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

• Brand Name: MAX POWER RELIEF TENS THERAPY UNIT
• Common Device Name: TENS
• Manufacturer (Section D): OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.; no. 28 vsip ii, st. 2,; vietnam-singapore indus. park; hoa phu thu dau mot city, 82000 0; VM 820000
• MDR Report Key: 20569820
• Report Number: 1450057-2024-00003
• Device Sequence Number: 20639276
• Product Code: NUH
• UDI-Device Identifier: 00073796635008
• UDI-Public: (01)00073796635008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2024
• Report Date (Section F): 10/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PM500
• Device Catalogue Number: PM500
• Device Lot Number: 202401V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2024
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 10/30/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/22/2024; 01/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/30/2024