MAUDE Adverse Event Report: SCANDINAVIAN HEALTH LTD. WHISPERJECT AUTOINJECTOR; INTRODUCER, SYRINGE NEEDLE

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous.Patient reported whisperject auto injector isn't working.Unknown if patient missed a dose unknown if there was a adverse event.Unknown if patient still has defective device.Unknown if md is aware.No further info.Reported to (b)(6) by pt/caregiver.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): SCANDINAVIAN HEALTH LTD.
• MDR Report Key: 13976592
• MDR Text Key: 288496387
• Report Number: MW5108684
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female