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

Lot Number 2612579

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Spontaneous.Patient reported she needs a new whisperject device because hers is broken since (b)(6) 2023.She was getting the injections done in the meantime at the hospital and also at her md office as well.Unknown if patient has missed a dose, experienced an adverse event, or if defective device is available for return.No further information.Reported to (b)(6) by: patient/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 18799403
• MDR Text Key: 336563986
• Report Number: MW5152090
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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 Age: 64 YR
• Patient Sex: Female