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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous call - patient reported no issues with the medication or syringe itself but advised the whisperject device spring broke.Patient uses the device to inject glatiramer 40 mg three times a week.No missed doses or adverse effects from defective product.Patient does have the device for manufacturer return.No additional information provided.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: 10546580
• MDR Text Key: 207589158
• Report Number: MW5096714
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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
• Patient Sequence Number: 1