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

Device Problem Failure to Deliver (2338)

Patient Problem Swelling (2091)

Event Date 05/21/2020

Event Type  Injury  

Event Description

Reporter of product complaint: pt.Summary of product complaint: pt states the "whisperer" did not start moving right after he injected with it: he kept it in his arm and waited on it to start giving the medicine.He now has a big red blood blister on the back of left arm the "size of a dime".Date of occurrence: (b)(6) 2020.Was the product taken/administered? yes.Can manufacturer call pt for follow up or pick up? yes.Lot number and expiration date unk.Md not aware.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: 10132852
• MDR Text Key: 194661075
• Report Number: MW5094895
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 61 YR