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U.S. Department of Health and Human Services

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

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EASYMED INSTRUMENTS CO. LTD OVIRA TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION Back to Search Results
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.
 
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Brand NameOVIRA
Type of DeviceTRANSCUTANEOUS 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 Key12607175
MDR Text Key281276525
Report Number3016442124-2021-00001
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
PMA/PMN Number
K140168
Number of Events Reported1
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
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOVIRA
Device Lot Number2010010
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/11/2021 Patient Sequence Number: 1
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