MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 2) OMRON ELECTROTHERAPY PAIN RELEIF; T.E.N.S UNIT

Model Number PM3030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Shock (2072); Numbness (2415)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

Exemption number e2013031.(b)(4).Incorrect manufacture report number was listed under follow-up mdr #1.Corrected manufacture report number from 3003263296-2015-00004 to 3003263296-2015-00002.Consumer was advised to return the unit for further investigation.A postage paid label was sent to retrieve the unit back for inspection.However, the end-user consumer did not return the unit for inspection.The manufacturer reviewed the dhr, 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 manufacture.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.

Manufacturer Narrative

Exemption number e2013031.(b)(4).Registration number (b)(4).Initial mdr was submitted in 2015, however was missing the mfr number even though the statement included the mdr was being submitted by importer and follow-up mdr included mfr numbers.So, this mdr is being submitted.Instruction manual provides following pain management warnings: if you have had medical or physical treatment for your pain, consult with your physician before using this device.If your pain does not improve, becomes seriously chronic or severe, or continues for more than five days, stop using the device and consult with your physician.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 advisable for you to use this electrotherapy unit.

Event Description

Consumer reported was shocked by unit in the middle of her back.The shock was very strong and she was using the unit on the lowest intensity level.It was a sharp pain from the shock.Per consumer shock lasted until her husband ripped the unit off her back.She had used the unit two times total.She went to the hospital after the shock.She is in constant pain and her hands and fingers go numb now.Consumer stated the pads still have gel on them.Consumer stated she wants to keep the unit to show her lawyer.Consumer was advised the unit is not to be used in the center of the back and stop using the unit.A postage paid label was sent to retrieve the unit back further investigation.During follow-up with quality analyst on (b)(6) 2015, the consumer stated she placed the unit on her upper back and the unit worked fine but the intensity in the left pad was weak.She moved the pads to her lower back and was immediately shocked.Her husband used the unit on his hands and also felt a shock.She woke up the next day and her back was stiff and her hands felt numb.She took no action at that time.Consumer stated after 2 weeks of her back not feeling better and the numbness not going away she went to the hospital.Consumer stated she is on muscle relaxers.She does have an existing medical condition.Consumer stated she was not admitted at the hospital and that the hospital recommended she see a neurologist.She is getting an mri this week.She is not sure if she will return the unit she wants to speak to her lawyer first.Consumer does not want the replacement unit, she wants the refund.Another follow-up call was made with customer on 06/15/2015.Consumer confirmed has pre-existing medical condition (herniated disc in neck).The unit shocked her and as a result she has pinched nerve and was in severe pain for 1 week.She has read instructions manual and using the unit as described in the manual.Consumer confirmed she does not have pacemaker or defibrillator or any other metal or plastic devices.She does not have medical insurance and cannot afford additional expenses such as going to see neurologist or having mri.Consumer refused to send the unit back for further investigation and indicated she wants to keep the unit for legal purposes as a proof.Consumer then stated she needs to get off the phone and hung up.

Manufacturer Narrative

Exemption number e2013031.Omron healthcare inc.,(importer)is submitting the report on behalf of omron healthcare co., ltd.Plant 2 (manufacturer).Registration number 3003263296.Follow-up mdr # 1 was submitted in 2015, however it had incorrect manufacture report number corrected manufacture report number from 3003263296-2015-00004 to 3003263296-2015-00002.Therefore, this mdr is being submitted again.Additional information added to section b5.The u.S agent and importer sent a postage paid label for retrieval of the unit for further testing.A letter was sent to consumer on 07/28/2015, indicating that consumer was advised to ship the unit for evaluation.However, the unit has not been received.

Event Description

Another contact was made with consumer on 07/02/2015.During follow-up, consumer stated the nerve damage has subsided.Consumer stated that, per her doctor, there is no permanent damage.She will return the unit today.Consumer is getting a refund for the unit and happy with the resolution.

• Brand Name: OMRON ELECTROTHERAPY PAIN RELEIF
• Type of Device: T.E.N.S UNIT
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 2); no. 28 dongbei er street, eco-; nomic & technical development; dalian liaoning, 11660 0; CH 116600
• Manufacturer (Section G): OMRON (DALIAN) CO., LTD. (PLANT 2); no. 28 dongbei er street, eco-; nomic & technical development; dalian liaoning, 11660 0; CH 116600
• Manufacturer Contact: renee thornborough ; 1925 w field court; suite 100; lake forest,, IL 60045-4824 ; 8472475626
• MDR Report Key: 5091922
• MDR Text Key: 188934506
• Report Number: 3003263296-2015-00002
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PM3030
• Device Catalogue Number: PM3030
• Device Lot Number: 20141149528UF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/15/2015
• Device Age: 6 MO
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female