MAUDE Adverse Event Report: MYLAN WHISPERJECT AUTOINJECTOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Pt reported whisperject malfunction and that button will not depress.She is continuing the medication.Dates of use: (b)(6) 2017 to ongoing.Diagnosis or reason for use: multiple sclerosis.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: WHISPERJECT AUTOINJECTOR
• Manufacturer (Section D): MYLAN
• MDR Report Key: 7163790
• MDR Text Key: 96466712
• Report Number: MW5074401
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1