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

Lot Number 8000007617

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous call from pt- patient reports received device on (b)(6) 2022 and started using it on (b)(6) 2022.It worked perfectly a couple of times and it does not work any longer.It would not release the medication.Patient is currently using autoinjector she has for copaxone for now.No missed dose or adverse event reported.Unknown if device available for return.Unknown expiration.No additional info.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 13677705
• MDR Text Key: 286933467
• Report Number: MW5107899
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 8000007617
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female