MAUDE Adverse Event Report: OMRON DALIAN CO., LTD 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 Shock (2072); Numbness (2415)

Event Date 06/01/2015

Event Type  Injury  

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 2 times total.She went to the hosp 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 for 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 wks of her back not feeling better and the numbness not going away, she went to the hosp.Consumer stated she is on muscle relaxers.She does have an existing medical condition.Consumer stated she was not admitted at the hosp and that the hosp 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 (b)(6) 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 wk.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

(b)(4).

• Brand Name: OMRON ELECTROTHERAPY PAIN RELIEF
• Type of Device: T.E.N.S UNIT
• Manufacturer (Section D): OMRON DALIAN CO., LTD; #28 dongbei er st, plant 2; economic & technical development zone; dalian 11660 0; CH 116600
• Manufacturer (Section G): OMRON DALIAN CO; #3 songiang rd; economic & technical development zone; dalian 1166 0; CH 11660
• Manufacturer Contact: renee thornborough ; 1925 w field ct; ste 100; lake forest, IL 60045 ; 8472475626
• MDR Report Key: 4855369
• MDR Text Key: 15393439
• Report Number: 1450057-2015-00004
• 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: 06/16/2015,06/09/2015

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: 20141149528UF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/09/2015
• Device Age: 6 MO
• Date Manufacturer Received: 06/09/2015
• 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