MAUDE Adverse Event Report: SHENZHEN ENOVART TECHNOLOGY CO., LTD INTIMATE ROSE VAGINAL DILATORS; DILATOR, VAGINAL

Device Problems Use of Device Problem (1670); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

Improper labeling and marketing for product.Intimate rose dilators are being tauted as the only fda registered dilator for vaginal dilation.However, on the fda site, this product is only approved for cervical dilation which this in no way does, and is causing confusion among patients and practitioners.See website https://www.Intimaterose.Com/collections/vaginal-dilators see fda report https://fda.Report/company/plus-ev-holdings-inc.

• Brand Name: INTIMATE ROSE VAGINAL DILATORS
• Type of Device: DILATOR, VAGINAL
• Manufacturer (Section D): SHENZHEN ENOVART TECHNOLOGY CO., LTD
• MDR Report Key: 16701015
• MDR Text Key: 313007431
• Report Number: MW5116435
• Device Sequence Number: 1
• Product Code: HDX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1