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

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Pt states that whisperject device malfunctioned and bent the needle of 1 galtiramer 40mg syringe.She states she thinks the spring broke in whisperject.She is able to give dose with another pfs.Provided mylan home number for pt to get replacement.

• Brand Name: WHISPERJECT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS, INC.
• MDR Report Key: 9069941
• Report Number: MW5089808
• Device Sequence Number: 19017193
• Product Code: KZH
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1
• Patient Age: 67 YR