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Model Number PM500 |
Device Problem
High impedance (1291)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 07/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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) 2022 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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Manufacturer Narrative
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Additional information added to section g6, h1, h2, h6 and h10.The device was not returned to the distributor/manufacturer for investigation.Here is the summary of the manufacturer device investigation: the manufacturer reviewed the production record 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.
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Search Alerts/Recalls
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