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

Device Problem Output Problem (3005)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091)

Event Date 08/01/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 pharmacist was notified that the pt has been experiencing slowness with the whisperject device which has caused painful injection site reactions - redness, pain, swelling.Contacting md to get a prescription for the whisperject device.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 8879489
• MDR Text Key: 154026410
• Report Number: MW5088927
• Device Sequence Number: 1
• Product Code: KZH
• UDI-Device Identifier: 00378696112
• UDI-Public: 00378696112
• Combination Product (y/n): Y
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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
• Patient Sequence Number: 1
• Patient Age: 21 YR