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

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient stated the whisperject jammed due to the needle not coming out, auto-injector broke as pt was using it.Rph added a replacement to the account.No other information available.No additional side effects mentioned by patient due to product issue.Lot number and expiration date are unknown.Unknown if patient still has product on hand.No further information was provided.Reported to (b)(6) by: patient/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Common Device Name: INTRODUCER SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 8405592
• Report Number: MW5084771
• Device Sequence Number: 18892005
• 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): 09/03/2018

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: 03/08/2019
• Patient Sequence Number: 1
• Patient Age: 54 YR