MAUDE Adverse Event Report: EASYMED INSTRUMENTS CO. LTD OVIRA; TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION

Model Number OVIRA

Device Problem Unintended Electrical Shock (4018)

Patient Problem Acoustic Shock (1693)

Event Date 09/10/2021

Event Type  Injury  

Event Description

The customer reported severe shock from the device resulting in pain down her left leg, hip and foot.For context, the device comes in two components: 1) the body of the device, and 2) the compression pads which adhere to the skin.The gels on the pads need to be replaced when they lose their 'stickiness'.The customer claims she experienced this issue when she replaced the sticky gels on the pads.The customer reported shock from the device resulting in pain down her left leg, hip and foot.The next day, she experienced pain in her left leg, foot, chest and arm.She sought medical attention and the er doctor advised it was nerve damage.The customer has not experienced any issues with the device prior to this incident.We are awaiting for the device, pads and accessories to be sent back to the manufacturer for further internal investigation.

• Brand Name: OVIRA
• Type of Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
• Manufacturer (Section D): EASYMED INSTRUMENTS CO. LTD; 3f-6f, block a, gupo gongmao b; fengxin rd, fengxiang indust; daliang, shunde, foshan, guangdong 52830 0; CH 528300
• MDR Report Key: 12607175
• MDR Text Key: 281276525
• Report Number: 3016442124-2021-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• PMA/PMN Number: K140168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OVIRA
• Device Lot Number: 2010010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 63