MAUDE Adverse Event Report: MYLAN WHISPERJECT INJECTOR; INTRODUCER, SYRINGE NEEDLE

Device Problems Break (1069); Detachment Of Device Component (1104); Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/24/2018

Event Type  Injury  

Event Description

Pt reported that his whisperject device is defective and requires replacement.He said that the orange button will not release and there seems to be a piece that has broken off.Prescriber aware.Reported to (b)(6) by: patient/caregiver.Dates of use: (b)(6) 2017 to (b)(6) 2018.Diagnosis or reason for use: multiple sclerosis.

• Brand Name: WHISPERJECT INJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN
• MDR Report Key: 7230549
• MDR Text Key: 98753112
• Report Number: MW5074977
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR