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

Lot Number 200135

Device Problem Entrapment of Device (1212)

Patient Problem Missed Dose (2561)

Event Type  malfunction  

Event Description

Percutaneous call from patient she reported that her glatiramer syringe is stuck in the whisperject autoinjector and will not come out (medication could not be injected).Obtained expiration date and lot number.We are to contact manufacturer within information and they will replace the patient's wasted glatiramer syringe.Patient did miss a dose.No adverse events reported.Unk if pt has device on hand for return.No further information provided by the patient.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 10396394
• MDR Text Key: 202804743
• Report Number: MW5096032
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/01/2021
• Device Lot Number: 200135
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1