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

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pt reporting she had 4 wasted doses of glatiramer and she thinks her whisperject auto injector is faulty.Pt reports 3 doses the medication dripped down her leg instead being injected [may 16,18, 20 2022].Then she tried to load a syringe in the injector last night may22 2022 but it was jammed and she couldn't load it.Pt reports she does have medication left, and she will take it to her doctor's office today to get an injection.No additional information available.Unknown if patient missed a dose.Unk if adverse event occurred.Unknown if patient currently possesses defective device.Unknown if specialist is yet aware.No further information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 14576237
• Report Number: MW5110056
• Device Sequence Number: 19531936
• Product Code: KZH
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLATIRAMER ACETATE (12X1ML) 40MG/ML
• Patient Age: 72 YR
• Patient Sex: Female