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

Device Problems Break (1069); Mechanical Problem (1384); Misfire (2532); Material Twisted/Bent (2981)

Patient Problem Swelling (2091)

Event Date 01/23/2019

Event Type  Injury  

Event Description

Whisperject injector for glatiramer acetate (generic copaxone) does not inject everytime, damages some needle, and causes egg size welts under surface of skin especially on legs and arms.I have spent the past several years using copaxone brand and its injector.Every time the insurance company makes me switch to generic glatiramer acetate and the whisperject injector there has been a problem with the injector misfiring, not injecting at all, difficulty in pressing switch; several times the injector forced the needle to bend ruining the entire dose.When we do get the injector to work properly it is on average only 1 in 3 of the weekly shots.When it does go well the place of injection has an egg size welt for about 3 to 4 days.Especially when injection on leg or arms.I am the patient and i do not have the hand strength to use any injector due to ms damage on right side.Husband must inject for me.This is the second time the insurance company has made me switch to generic even though i reported these same issues last year to (b)(6) pharmacy and fda.Neurologist office filled out paperwork on incident to insurance and medical exception was denied.Dates of use: begin generic (b)(6) 2019.Diagnosis or reason for use: multiple sclerosis.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC; morgantown WV
• MDR Report Key: 8320788
• MDR Text Key: 135909303
• Report Number: MW5083851
• Device Sequence Number: 1
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 93