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

Lot Number 14252002

Device Problems Crack (1135); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Spontaneous call from (b)(6) from hub of glatiramer acetate asking if pt got his replacement for whisperject autoinjector from (b)(6) 2018 for replacement.Pt told (b)(6) he did not received whisperject autoinjector - called pt and conferenced with (b)(6) and she asked pt about whisperject; pt stated, needs a replacement for whisperject autoinjector due to one he has is bent and cracked.Informed will go ahead and have rph put in a new rx for whisperject.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 9161699
• MDR Text Key: 161527377
• Report Number: MW5090243
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/25/2019
• Device Lot Number: 14252002
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1