MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS INC. 1-WHISPERJECT AUTOINJECTOR; INTRODUCER, SYRINGE NEEDLE

Device Problems Mechanical Problem (1384); Inaccurate Delivery (2339)

Patient Problem Underdose (2542)

Event Type  malfunction  

Event Description

Who gave you information? patient.What is the complaint about the product? when she presses the blue button the spring releases but the syringe does not empty.Patient reports the red button doesn't show up and when she removes the injection from her skin the medication appears to spray out.Patient reports she tried 3 times and this happened each time.Was the product taken or administered? patient is unsure if she received any of the doses; what is the lot number? patient states she does not have a lot number; can the manufacturer call the patient for follow up if necessary? yes; can the manufacturer arrange for product pick up: yes; md not aware-patient will make md aware.Reported to (b)(6) by pt/caregiver.

• Brand Name: 1-WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 10535052
• MDR Text Key: 207179614
• Report Number: MW5096616
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1