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

Health Effect - Clinical Codes	Erythema (1840); Pain (1994)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt stated had issue with whisperject that caused medication to cause a very painful large red welp at injection site where "it looked like it busted open in the middle".

• Brand Name: WHISPERJECT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS, INC
• MDR Report Key: 9824496
• Report Number: MW5093706
• Device Sequence Number: 13358256
• Product Code: KZH
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1