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 Chest Pain (1776); Neck Pain (2433)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

Exemption number e2013031 (b)(4).Registration number 3003263296.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 used 1 pad on left inner thigh and 1 on right leg on the top of leg for 25 minutes.Consumer stated does already have numbness in the right leg which is not from the unit.Consumer reported getting a little shock in his left testicle, went to bed, woke up with pain in his left jaw which got worst during the day.Consumer claimed went to dentist who referred to him to specialist.Customer claims did not feel yesterday, was feeling jolty, tingling, dizzy, lightheaded, like he was in a cloud, shortness of breath.Customer claims there was pain in middle of chest, in his head, neck, eyes, pain in his right shoulder blade which he did not put unit on that area.He was starting to sweat yesterday.Consumer reported still has some pain today, nausea.He was using the unit on 2-3 intensity.Customer was advised proper locations to place the pads.Customer was advised to stop using the unit.A postage paid label has been sent to retrieve the unit for inspection.5/28/2015- quality analyst (qa) called customer to follow-up.No answer.Qa left message with consumer requesting a call back.05/28/2015-qa called again consumer to follow-up.Unable to reach consumer left message requesting a call back.06/1/2015-qa spoke to customer's mother.Per the customer's mother, her son is currently at the hospital but does not know if he had been admitted.He went to hospital on the day of the issue ((b)(6) 2015) because numbness and tingling in his legs.He was not admitted.She would call back if he gets admitted or will have customer call back if he does not get admitted.Per the mother, customer has contacted a lawyer due to the issue the unit has caused him.06/15/2015- qa called customer to obtain additional information regarding this report.Consumer's mother answered the call and indicated user is not available and she will have him call back.She did not want to provide any additional information.

Manufacturer Narrative

Exemption number e2013031.(b)(4).Added mfr.Report number (3003263296-2015-00001) since it was inadvertently omitted from initial report.Additional information: 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.

• 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: 5104271
• MDR Text Key: 189669661
• Report Number: 3003263296-2015-00001
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• 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: 20140915965UF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/15/2015
• Device Age: 8 MO
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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