MAUDE Adverse Event Report: IPLEDGE; MEDICAL DEVICE DATA SYSTEM

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Transmit Record (1521); Problem with Software Installation (3013)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Can't use the ipledge website for isotretinoin to start this patient.The website is a disaster since the change to a new system was implemented 12/13/2021.Other patients who were previously registered are not showing up.There is no support or information to contact.It is going to affected this patient's ability to get her medication as well as other patients.Fda safety report id # (b)(4).

• Brand Name: IPLEDGE
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• MDR Report Key: 13019815
• MDR Text Key: 282421694
• Report Number: MW5106114
• Device Sequence Number: 1
• Product Code: OUG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female