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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Skin Inflammation (2443)

Event Date 02/09/2018

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.Per labeling instructions in the instruction manual "do not use this unit with these other devices: (1).If you have a pacemaker, e implanted other devices: defibrillator, or other implanted metallic or electronic device.Such use could cause electric shock, burns, electrical interference or death.".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 she went to the doctor and her doctor increased her pain medication and gave medication for inflammation, this medwatch is being filled.

Event Description

Consumer reported since she has been using unit, it has caused more pain.She has had back surgery and has screws, bolts and rods in her back.She has not sought treatment for the pain.She was not able to sit up because it caused too much pain.She did not know until after she used it that she should not be.She is the only user and has been using the unit once a day.She started using the unit on (b)(6) 2018.She is using the unit for 15 minutes each use.Per consumer, the pads were placed on each side of her spine on her lower back and were placed one inch apart.Consumer stated the intensity level was on 3 and on (b)(6) 2018 she had it turned up to 5.Consumer was advised to stop using the unit by the customer service representative.Consumer was sent postage paid label to retrieve the unit.Consumer was advised the unit is not recommended to use with metal on her back.Customer service representative advised consumer to inform quality department if she goes to doctor.Consumer requested refund since could not use the unit.During follow-up with quality analyst, consumer stated she is experiencing pain from the unit.Consumer confirmed she has screws, rods and bolts in her back.She had the unit for 2 weeks, used it once a day for 15 minutes and is the only user.She still has the pain and is going to emergency room tonight.Consumer agreed to send the unit for further investigation.Qa called the consumer again to get more information about her er visit.Consumer stated she was in emergency room for 12 hours waiting.She could not get treatment because after waiting for so long she had to leave.She is going to call her rheumatoid arthritis doctor and see if she can get some pain medication.Stated she had back surgery in (b)(6) of last year.During another follow-up call, consumer stated she did go to doctor for the pain that she was experiencing after using the tens unit.Per the consumer, she had inflammation on her back and the pain kept waking her up at night.She was restless.Her doctor increased her pain medication and gave her medication for inflammation.Consumer stated she was told to be less mobile in order to keep her body from stressing it.Qa asked if the doctor indicated or advised her not use the unit or not? consumer stated no.Consumer confirmed she had back surgery due to bulging disk (s3, s4 and s5) and her lower back was broken.Consumer confirmed she has been on disability prior to using the unit.She was using pain medication patches prior to using the tens unit.The pain patches were costing her (b)(6) so she decided to try the tens unit.Consumer confirmed that she was not aware that she should not use the unit until after she experienced increased pain and then she read the instruction manual.

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: (b)(4).The unit was returned on 03/07/2018.The returned unit was evaluated by importer (u.S agent) and it passed the initial evaluation.The customer returned unit was then sent to the device manufacturer for further investigation.Here is the summary of the manufacturer device investigation: the unit was tested and it passed all specification tests.The manufacturer reviewed the qa test data and complaint history for similar issues.No issue or increasing trend was noted.It was determined that user misuse of the device caused this event.The instruction manual includes the instructions related to the use of the device with implanted metallic or electronic device.The risk analysis document was reviewed and it was determined that no update to risk management documents is required.Since there was no issue found with returned device; further investigation and correction is not necessary.

• 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 liaoning, 11660 0; CH 116600
• MDR Report Key: 7297528
• MDR Text Key: 101002354
• Report Number: 3003263296-2018-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• PMA/PMN Number: K141978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• 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: 20170708623UF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2018
• Device Age: 7 MO
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR