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

Device Problems Connection Problem (2900); Material Twisted/Bent (2981); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pt stated, "i was on copaxone and had their injector kit for years without any issues.Now suddenly i received the generic and the needles bend the injector is awful.It's hard to use doesn't stay together so i haven't been able to take my medication in over two weeks.No side effects reported due to missed doses.Reported for both the injector and the glatiramer due to pt saying the glatiramer needles bend the injector and the injector doesn't stay together.No ade reported; unknown if device available for return; unknown lot/expiration.No further information known.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: 11507122
• MDR Text Key: 240789117
• Report Number: MW5100067
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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