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 12/03/2019

Event Type  Injury  

Event Description

Pt just received whisperject device and states that it is not working.Pt has previous experience with similar self injectables.Pt states that she has tried several times, following the instructions included with the device, to administer her medication.States that the device will not inject the medication.

• Brand Name: WHISPERJECT DEVICE
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS, INC.
• MDR Report Key: 9437984
• MDR Text Key: 170041929
• Report Number: MW5091528
• Device Sequence Number: 1
• Product Code: KZH
• UDI-Device Identifier: 00400527460
• UDI-Public: 00400527460
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR