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

Device Problem Failure to Deliver (2338)

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

Event Date 01/03/2020

Event Type  Injury  

Event Description

Pt did not have any issues with device until (b)(6) 2020 when she was unable to administer her dose.She did not see any defects with the device, no caps stuck inside the end of the device.She is unable to push the button to discharge the needle.She is unable to administer medication without the device and does not have another person to assist her with the injection.Pharmacist provided mfr's phone number.

• Brand Name: WHISPERJECT DEVICE
• Type of Device: INTRODUCER SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 9564452
• MDR Text Key: 174313256
• Report Number: MW5092096
• Device Sequence Number: 1
• Product Code: KZH
• UDI-Device Identifier: 00400527460
• UDI-Public: 00400527460
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR