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

Device Problem Use of Device Problem (1670)

Patient Problem Reaction, Injection Site (2442)

Event Date 08/06/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, pt reports that she had to stop using the whisperject device because she felt it was too shaky and difficult for her.She says manual injections are going okay but she has burning and welts when she injects in her thighs.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 8888406
• MDR Text Key: 154272640
• Report Number: MW5088970
• Device Sequence Number: 1
• Product Code: KZH
• UDI-Device Identifier: 00378696112
• UDI-Public: 00378696112
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR