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U.S. Department of Health and Human Services

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

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ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS, RELIEV; DEVICE, ACUPRESSURE Back to Search Results
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).
 
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Brand Name
ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS, RELIEV
Type of Device
DEVICE, ACUPRESSURE
MDR Report Key15959044
MDR Text Key305290754
Report NumberMW5113725
Device Sequence Number1
Product Code MVV
Combination Product (y/n)N
Number of Events Reported1
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 Received12/09/2022
Patient Sequence Number1
Treatment
NO PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USED
Patient Outcome(s) Required Intervention; Disability;
Patient Age28 YR
Patient SexMale
Patient Weight102 KG
Patient EthnicityNon Hispanic
Patient RaceAsian
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