MAUDE Adverse Event Report: ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS, RELIEV; DEVICE, ACUPRESSURE

Device Problem Output Problem (3005)

Patient Problems Erythema (1840); Blister (4537)

Event Date 09/26/2022

Event Type  Injury  

Event Description

I bought a medical treatment wristband named "anti-nausea wristband, rechargeable relieve nausea motion sickness bands, relieve nausea electrode stimulator wrist bands relief for anxiety, migraine, motion sickness" on amazon recently.Website:https://www.Amazon.Com/dp/b0b7b7g92p i used the wristband follow the instructions.Unfortunately it made me uncomfortable and i found some erythema and blisters appeared on my wrist.I took two pictures of my wrist and i put them in the attachment of this document.I searched this wristband name on the website of fda establishment registration and device listing and 510(k) premarket notification, but i could not get any records in fda databases.I wonder how could amazon permit this medical treatment wristband shelved without fda establishment registration or 510(k) premarket notification.What's more, i collected some information through it's web page on amazon.(b)(6).

• Brand Name: ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS, RELIEV
• Type of Device: DEVICE, ACUPRESSURE
• MDR Report Key: 15959044
• MDR Text Key: 305290754
• Report Number: MW5113725
• Device Sequence Number: 1
• Product Code: MVV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/08/2022

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2022
• Patient Sequence Number: 1
• Treatment: NO PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USED
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian