MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS INC. WHISPERJECT; INTRODUCER, SYRINGE NEEDLE

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous communication from the patient to report that whisperject device is not working properly but no issue with glatiramer.No additional information to provide at this time.Unknown the exact issue/problem with the whisperject device.Unknown if patient missed a dose.Unknown if device is available for manufacturer to pick-up.Note: no rx exists for whisperject, therefore, glatiramer rx chosen, so event could be reported.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 12446158
• MDR Text Key: 270793626
• Report Number: MW5103775
• Device Sequence Number: 1
• Product Code: DYB
• 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: 05/10/2021

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1