MAUDE Adverse Event Report: PIATREI MOTION SICKNESS BANDS; DEVICE, ACUPRESSURE

Patient Problems Dyspnea (1816); Tachycardia (2095); Loss of consciousness (2418)

Event Date 12/27/2023

Event Type  Injury  

Event Description

I purchased a piatrei motion sickness bands from amazon.Com asin: (b)(6).After using, i felt my heart racing, shortness of breath, and even fainted.This product is advertised to be fda approved, i looked for this product in the fda database but could not find it, i felt i was being scammed and even endangered my life.Can the fda regulate medical products sold on amazon shelves more to protect consumers' lives? (b)(6).

• Brand Name: PIATREI MOTION SICKNESS BANDS
• Type of Device: DEVICE, ACUPRESSURE
• MDR Report Key: 18437557
• MDR Text Key: 331925091
• Report Number: MW5149744
• 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: 12/28/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White