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

Lot Number B000007617

Device Problem Mechanical Problem (1384)

Patient Problem Missed Dose (2561)

Event Type  malfunction  

Event Description

The patient received the first whisperject device and after a month of use, she states that the plunger would no longer depress.We sent her another device and she is stating that the second whisperject device is not working now with the same issue.Provided phone number for hub to call for replacement and also counseling information to make sure she is using properly.Patient has missed doses of medication, but has not had any adverse effects.Device is available for retrieval.Used with glatiramer injections.No other information provided.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): SCANDINAVIAN HEALTH LTD / MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 10559706
• MDR Text Key: 207903399
• Report Number: MW5096751
• 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: 09/01/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/25/2021
• Device Lot Number: B000007617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1