MAUDE Adverse Event Report: OMRON HEALTHCARE, INC. OMRON ELECTROTHERAPY PAIN RELIEF; 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  

Event Description

Consumer reported used 1 pad on left inner thigh and 1 on right leg on the top of leg for 25 mins.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 him to a specialist.Customer claims did not feel well yesterday, was feeling jolty, tingling, dizzy, lightheaded, like 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.On (b)(6) 2015, quality analyst (qa) called customer to follow-up.No answer.Qa left message with consumer requesting a call back.On (b)(6) 2015, qa spoke to customer's mother.Per the customer's mother, her son is currently at the hosp but does not know if he had been admitted.He went to hosp on the day of the issue ((b)(6) 2015) because of 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.On (b)(6) 2015, qa called customer to obtain addt'l info regarding ths 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 addt'l info.

Manufacturer Narrative

(b)(4).

• Brand Name: OMRON ELECTROTHERAPY PAIN RELIEF
• Type of Device: T.E.N.S UNIT
• Manufacturer (Section D): OMRON HEALTHCARE, INC.; #28 dongebei er st, plant 2; economic & technical development zone; dalian 11660 0; CH 116600
• Manufacturer (Section G): OMRON DALIAN CO, LTD; #3 songiang rd; economic & technical devleopment zone; dalian 1166 00; CH 116600
• Manufacturer Contact: renee thornborough ; 19525 w field ct; ste 100; lake forest, FL 60045 ; 8472475626
• MDR Report Key: 4855370
• MDR Text Key: 20441531
• Report Number: 1450057-2015-00003
• 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: Distributor
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/16/2015,05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/28/2015
• Device Age: 8 MO
• Date Manufacturer Received: 05/28/2015
• 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