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

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Missed Dose (2561)

Event Date 09/16/2020

Event Type  malfunction  

Event Description

Spontaneous - pt assembled glatiramer syringe into autoinjector and stated when she went to inject medication and pushed down on orange/yellow button to inject medication, the button was stuck.Pt does not have information on whisperject device.She stated she does not need medication replacement, she just needs new whisperject device.She missed wednesday dose and is due for next dose tomorrow.Pt does not have lot/expiration date information for whisperject device.Product unavailable for return.No further information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT AUTO INJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 10559866
• MDR Text Key: 207967321
• Report Number: MW5096763
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR