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

Device Problem Failure to Deliver (2338)

Patient Problem Bruise/Contusion (1754)

Event Type  malfunction  

Event Description

Spontaneous.Member reports bruising and medication not being "released" by whisperject device.Unknown if pt missed a dose; unknown if available for return; unknown lot/expiration.No further information known.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: 12487595
• MDR Text Key: 272465934
• Report Number: MW5104042
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1