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

Lot Number 2612579

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pt stated autoinjector broken.Dose and frequency: inject 1 syringe under the skin 3 times a week at least 48 hours apart on the same 3 days each week.Unknown if pt missed a dose, experienced an adverse event or if product on hand for return.Unknown if provider is aware.Spontaneous.Reported to (b)(6) by: patient/caregiver.

• Brand Name: WHISPERJECT AUTO INJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 18475347
• MDR Text Key: 332637361
• Report Number: MW5149955
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 2612579
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: GLATIRAMER ACETATE (12X1 ML).
• Patient Sex: Female