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

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Reporter of product complaint: patient; type of device: whisperject auto injector; summary of product complaint: whisperject device jammed and won't release medication; date of occurrence: unknown; was the product taken/administered?: no- dose missed-no side effects associated with missed dose; can manufacturer call patient for follow up?: yes; can manufacturer arrange for product pick up?: yes; what is the lot number? unknown- patient unable to locate; md not made aware- call made.Reported to (b)(6) by: patient/caregiver.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 13977263
• MDR Text Key: 288589023
• Report Number: MW5108714
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female