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

Lot Number 11423

Device Problem Break (1069)

Patient Problem Missed Dose (2561)

Event Type  malfunction  

Event Description

Who gave you information? husband; what is the complaint about the product? the injector is broken, will not dispense medication; was the product taken or administered? no; unknown if patient experienced any side effects what is the lot number? # 11423; can the manufacturer call the patient for follow up if necessary? yes; can the manufacturer arrange for product pick up? yes.Md aware/drug on hold.Reported to (b)(6).

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 10535046
• MDR Text Key: 207171706
• Report Number: MW5096615
• 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
• Device Lot Number: 11423
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1