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

Device Problem Use of Device Problem (1670)

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

Event Date 01/31/2019

Event Type  No Answer Provided  

Event Description

Patient reported that she had issues using her whisperject and, as a result, wasted a dose of medication.She stated that she was going to reach out to the manufacturer to discuss.The product is not compounded.The product is not over-the-counter.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 8315824
• MDR Text Key: 136013072
• Report Number: MW5083821
• Device Sequence Number: 1
• Product Code: KZH
• UDI-Device Identifier: 00378696112
• UDI-Public: 00378696112
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR