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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Reporter of product complaint: patient; summary of product complaint: patient stated she missed dose last night due to whisperject did not work.Unknown if patient experienced any side effects; date of occurrence: (b)(6) 2021; was the product taken/administered?: no; can manufacturer call patient for follow up?: yes; can manufacturer arrange for product pick up? yes; md not aware- patient will follow up with md.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: 11938304
• MDR Text Key: 254485663
• Report Number: MW5101696
• Device Sequence Number: 1
• Product Code: KZH
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 76 YR