MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. BELIFU TENS UNIT; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE COUNTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Irritation (2076)

Event Date 11/10/2020

Event Type  Injury  

Event Description

Reports has had sharp pains, skin irritation burns, itching, redness, for several days after using this device.

• Brand Name: BELIFU TENS UNIT
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE COUNTER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
• MDR Report Key: 10837737
• MDR Text Key: 216411736
• Report Number: MW5097866
• Device Sequence Number: 1
• Product Code: NUH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 91