MAUDE Adverse Event Report: OWEN MUMFORD, LTD. AUTOINJECTOR; INTRODUCER, SYRINGE NEEDLE

Device Problem Break (1069)

Patient Problem Missed Dose (2561)

Event Date 04/13/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the patient reports missing two doses of copaxone due to breaking her injector.

• Brand Name: AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): OWEN MUMFORD, LTD.
• MDR Report Key: 9962194
• MDR Text Key: 187772379
• Report Number: MW5094141
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1