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

Model Number PM3032

Device Problem Failure to Conduct (1114)

Patient Problem Burn(s) (1757)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Consumer was advised to stop using the unit.A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.The u.S importer is requesting manufacture of the device to further investigate this incident.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 stating that her doctor had recommended skin graft, this medwatch is being filed.

Event Description

Consumer reported the unit has burned her back.She has blisters on her lower back from the pad.This is her first time using the unit.She was placing the pads on her lower back only.She only let the unit run for the 15 minutes.She is using the batteries that came with the unit.She did not add any lotion or perfumes before placing the pads on her back.Consumer stated one pad that was not giving any stimulation is the one that burnt the back.She had not sought medical treatment.She has not added any ointment to the area.She does not see any damage to the cords.She had the intensity up to a 6.Consumer was advised to stop using the unit and was sent the postage paid label to retrieve the unit for further investigation.During follow-up call with quality analyst, the consumer stated the unit is brand new and she is the only user and only used the unit one time, this morning.She has used the tens therapy before at rehab so she knows what to expect with it.She turned the unit on at level 6 intensity.She could feel the stimulation only on one of the pads.When she took the pads off and she had a dark red burn the shape of the pad (the pad that she did not feel the stimulation on).She also has 2 blisters where the pad took off her skin.She used the unit on her lower back.She would send the pictures of the burn.Her back was dry and free from lotion or oils.She wants a refund and not a replacement.Consumer did not indicate any medical treatment or intervention as a result of the event.Consumer was provided with instructions for sending the unit for inspection (further investigation).Consumer stated she will return the unit back for inspection.Consumer sent the pictures of the burn to quality analyst.Quality analyst had noted that aspercreme was purchased at the same time the unit was purchased on 05/24/2017.Another follow-up call was made with consumer to obtain additional information.Consumer confirmed that she did not use aspercreme or any other lotions and her skin was dry before she used the tens unit.Consumer indicated she has the artificial heart valve (which is made of carbon and not metallic or electronic).She did read the instructions manual prior to using the machine.She has the pre-existing conditions of heart issue and had hemorrhagic brain bleed and has back issues.She is on coumadin and monitors her inr at home.Consumer was upset and stated it and only thing we are doing refunding the money and hung up the phone.Consumer had sent a second email on 05/25/2017 with pictures and wrote that this is how the burn is tonight.It is very painful; i will try and get treatment tomorrow if i can walk with the original back problem still ongoing.Another email from consumer was received on 05/30/2017 with pictures and wrote following: this is a follow up photo of what your product did to my back.You can distinctly see the pattern of the pad on my skin.I am able to drive enough to get to my doctor today, and i am contacting my lawyer concerning your products failure.On 06/05/2017, then the consumer called and spoke to executive director qa/ra.Consumer stated the burns have started to heal.The burns got worse before they got better.She went to doctor last wednesday ((b)(6) 2017).Consumer stated her doctor has recommended a skin graft.She has contacted lawyer.She was disappointed that there was no follow up.The consumer stated the burns are healing and consumer did not state she has received a skin graft it was only a recommendation by her doctor.

Manufacturer Narrative

Exemption number: e2013031.Omron healthcare.Inc.(importer) is submitting the report on behalf of omron (dalian) co., ltd.(plant 2) (manufacturer).Registration number: 3003263296.Quality analyst had sent postage paid label and refund for the unit, to facilitate retrieval of the unit for further investigation.As of 08/01/2017, unit has not been received after multiple attempts made to retrieve the unit.The manufacturer reviewed the device history record, qa test data and risk analysis, complaint history for the model number and similar models and complaint records for similar issues.No issue/problem was noted during data reviewed by the manufacturer.All risk mitigations, warnings and cautions are still correct and in place.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

Event Description

Additional follow-up information received from consumer: quality analyst contacted consumer (on (b)(4) 2017) to obtain additional information.Consumer stated the burn has healed and is now just a scar.Her doctor recommended she go to a wound clinic but since it has healed on it's own she did not go.She will be making an appointment/consultation with a surgeon to discuss plastic surgery.She is calling the surgeon today to make an appointment.Quality analyst advised that we may call back for information regarding the appointment and consumer stated that would be fine.Consumer stated she has no allergies.She will send picture of her scar.She still is not sure what her next steps are and/or if she will send in the unit.During another follow-up was with consumer on (b)(4) 2017 by quality analyst, consumer stated she saw her surgeon yesterday and is waiting to receive a "report" from him.She doesn't think she'll get surgery at this time she wants to wait to see how the wound heals.She is not sure what she will do with the unit.Consumer stated she will call me back once she figures everything out.As of (b)(4) 2017, consumer has not provided any additional information.

• Brand Name: OMORN MAX POWER 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, 11660 0; CH 116600
• Manufacturer (Section G): OMRON (DALIAN) CO., LTD. (PLANT 2); no. 28 dongbei er street, eco-; nomic & technical development; dalian, 11660 0; CH 116600
• Manufacturer Contact: renee thornborough ; 1925 w field court; suite 100; lake forest, IL 60045-4824 ; 8472475626
• MDR Report Key: 6635587
• MDR Text Key: 77419172
• Report Number: 3003263296-2017-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PM3032
• Device Catalogue Number: PM3032
• Device Lot Number: 20160705016UF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2017
• Device Age: 10 MO
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other