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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 1) MAX POWER RELIEF TENS THERAPY
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OMRON (DALIAN) CO., LTD. (PLANT 1) MAX POWER RELIEF TENS THERAPY Back to Search Results
Model Number PM500
Device Problem High impedance (1291)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 07/09/2022
Event Type  Injury  
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 being burned by the unit this medwatch is being filed.The product instruction manual includes the following: start with one 15-minute session.Rate your pain to check your progress, 1 low to 10 high.Stop therapy session if pain has reduced or stopped.Press the "on" button to continue therapy for another 15-minute session.If you experience any skin irritation or redness after a session, do not continue stimulation in that area of the skin.The consumer stated she returned her unit to the retailer so she would not be sending it in for further investigation.
 
Event Description
The consumer stated that her tens unit burned her back.She had back spasms and experienced burns that hurt to the touch.The issue occurred on (b)(6) 2022.The burns were on her lower back where the pads were placed.The pads were applied for over an hour with two treatments.It was the first time she used the unit.The unit was set to 1 then she went up to 10.She did not have a reaction when using a tens unit at her doctor's office.She used the pads on dry, clean skin.During the first treatment, she was sitting up, and she lied down for the second treatment.She stated the burns looked marbleized and were pink and purple in color.The burns were two big circles the size of apples with small circles in the middle.The burns did have bumps, but they were not blistering.She did not treat the burns.She stated when she showered, the burns hurt, and they were sore to touch.She returned her tens unit to walgreens.She may have the receipt, but she did not want to look for it.She made an appointment with her chiropractor on (b)(6) due to the burns.Her chiropractor did not prescribe anything for treatment.The doctor stated the burns may scar and are electrical burns.She was requesting a refund of $50 for her chiropractor visit.She stated she could not seek medical attention since she was not at home and her insurance does not cover the doctor or er.She asked if it would be lifetime damage, and she was advised that only a physician is qualified to answer that question.She stated she would call back if she had to seek medical attention.She did not receive a refund since she already returned her unit.She did not want a replacement unit.
 
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 being burned by the unit this medwatch is being filed.The product instruction manual includes the following: - start with one 15-minute session.Rate your pain to check your progress, 1 low to 10 high.Stop therapy session if pain has reduced or stopped.Press the "on" button to continue therapy for another 15-minute session.- if you experience any skin irritation or redness after a session, do not continue stimulation in that area of the skin.The consumer stated she returned her unit to the retailer so she would not be sending it in for further investigation.Additional information added to section h10 after investigation by the manufacturer.The device was not returned to the distributor/manufacturer for investigation.The investigation was closed on 9/29/2022.Here is the summary of the manufacturer device investigation: the manufacturer reviewed the qa test 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.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.
 
Event Description
The consumer stated that her tens unit burned her back.She had back spasms and experienced burns that hurt to the touch.The issue occurred on july 9th, 2022.The burns were on her lower back where the pads were placed.The pads were applied for over an hour with two treatments.It was the first time she used the unit.The unit was set to 1 then she went up to 10.She did not have a reaction when using a tens unit at her doctor's office.She used the pads on dry, clean skin.During the first treatment, she was sitting up, and she lied down for the second treatment.She stated the burns looked marbleized and were pink and purple in color.The burns were two big circles the size of apples with small circles in the middle.The burns did have bumps, but they were not blistering.She did not treat the burns.She stated when she showered, the burns hurt, and they were sore to touch.She returned her tens unit to walgreens.She may have the receipt, but she did not want to look for it.She made an appointment with her chiropractor on (b)(6) due to the burns.Her chiropractor did not prescribe anything for treatment.The doctor stated the burns may scar and are electrical burns.She was requesting a refund of $(b)(6) for her chiropractor visit.She stated she could not seek medical attention since she was not at home and her insurance does not cover the doctor or er.She asked if it would be lifetime damage, and she was advised that only a physician is qualified to answer that question.She stated she would call back if she had to seek medical attention.She did not receive a refund since she already returned her unit.She did not want a replacement unit.
 
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Brand Name
MAX POWER RELIEF TENS THERAPY
Type of Device
TENS
Manufacturer (Section D)
OMRON (DALIAN) CO., LTD. (PLANT 1)
no. 3 songjiang rd., economic
technical development zone
dalian, 11660 0
CH  116600
MDR Report Key15032609
MDR Text Key296044861
Report Number1450057-2022-00005
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 Other
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberPM500
Device Catalogue NumberPM500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/15/2022
Distributor Facility Aware Date07/11/2022
Event Location Home
Date Report to Manufacturer07/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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