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

Device Problem No Flow (2991)

Patient Problem Missed Dose (2561)

Event Date 12/12/2018

Event Type  Injury  

Event Description

Patient¿s whisperject malfunctioned.Patient has wasted 2 syringes now as it will not inject.She did not want to inject without the autoinjector and wanted a replacement.Provided mfg number for replacement on the autoinjector and 2 syringes that were wasted.Patient will miss a dose due to apprehension on injecting without a device.Dates of use : (b)(6) 2018- present; diagnosis or reason for use: g35.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 8189780
• MDR Text Key: 131466402
• Report Number: MW5082405
• Device Sequence Number: 1
• Product Code: FMF
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 75 YR