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

Model Number B000007617

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

The whisperject continues to malfunction.This is my fourth device and all have the same problem.After loading the syringe, the mechanism does not work consistently.Basically, the patient cocks the device by pushing one end of the device into the other until a clicking sound is heard.The patient then pushes the orange button to get the syringe moving into the injection site.It works sometimes but not always.When it does not work, the syringe does not move and i need to try to remove the syringe without it's flying across the room to inject myself.I have multiple sclerosis and use of both hands to administer a shot is near impossible, so that is why i need to use this device.I have had numerous conversations with (b)(4) and (b)(4), asking me whether i have done certain things correctly.Believe me, i have! the device works perhaps 1/3 of the time, which is unacceptable to a patient.I had been a user of copaxone for a number of years before being switched by my insurance company to glatiramer acetate and never had a problem with their injection device, not once in probably 5 years.Whisperject is an inferior product and should be removed from production.Fda safety report id # (b)(4).

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN / SCANDINAVIAN HEALTH LTD.
• MDR Report Key: 13506397
• MDR Text Key: 285529487
• Report Number: MW5107349
• Device Sequence Number: 3
• Product Code: KZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B000007617
• Patient Sequence Number: 1
• Treatment: ALEVE; BACLOFEN; GABAPENTIN; GLATIRAMER ACETATE; MEDOXOMIL; NEUPRO PATCH; OLMESARTAN
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White