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

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Spontaneous call from pt who advised that there is a defect with the whisperject autoinjector.Pt stated that she loaded the injector but when pressed, nothing comes out.Call to mylan (mfr) spoke to (b)(4) (rn) she states that more than likely pt is using it incorrectly, and she will speak with her to troubleshoot.She also advised that if it does not work, will contact (b)(6) to have rph obtain new rx from mdo for whisperject autoinjector.No other info known.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 8888879
• MDR Text Key: 154408071
• Report Number: MW5088984
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): Y
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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
• Patient Sequence Number: 1