MAUDE Adverse Event Report: UNKNOWN ANTI-NAUSEA WRISTBAND; DEVICE, ACUPRESSURE

Model Number NOT MARKED

Device Problems Product Quality Problem (1506); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Blister (4537)

Event Date 09/29/2022

Event Type  malfunction  

Event Description

I recently bought a "anti-nausea wristband, rechargeable relieve nausea motion sickness bands ,relieve nausea electrode stimulator wrist bands relief for anxiety, migraine, motion sickness (car, air, train, sea)" is a medical wristband.Asin: (b)(4) link: https://www.Amazon.Com/dp/(b)(4) i used the wristband according to the instructions.Unfortunately, it made me uncomfortable and i noticed some redness and blisters on my wrist.I took two photos of the appearance of the adverse reaction and placed them in the attachment to this document.I searched the fda website for the name of this wristband, but i have no record of it in the fda database.This product is a class ii medical device in the united states.How did it manage to be sold in the us sales market to the average american user without fda registration or obtaining a 510(k) premarket notification.I have suffered severe adverse reaction experiences and would like this product to be fda safe for regulation.Please prohibit the sale of this product until it is approved so that it does not pose a threat to the safety of more users.Fda safety report id # (b)(4).

• Brand Name: ANTI-NAUSEA WRISTBAND
• Type of Device: DEVICE, ACUPRESSURE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15690972
• MDR Text Key: 302780756
• Report Number: MW5112958
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NOT MARKED
• Device Catalogue Number: NOT MARKED
• Device Lot Number: NOT MARKED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Male