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

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Reporter: pt.Summary: whisperject failed when attempted injection.The cap popped off, medication emptied without administering dose.It is unk if the pt missed a dose or had any other pen in hand to use.Date of occurrence: unk.Was the product taken / administered? no.Can mfr call pt for f/u? yes.Can mfr arrange for product pick up? yes.Lot number unk, pt was not able to read the writing on auto-injector.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 9506259
• Report Number: MW5091830
• Device Sequence Number: 10688080
• Product Code: KZH
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2019
• Patient Sequence Number: 1