MAUDE Adverse Event Report: AUTOINJECTOR; INTRODUCER, SYRINGE NEEDLE

Device Problem Break (1069)

Patient Problems Underdose (2542); No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

Event Description

Pt reported on (b)(6) 2019 that he was on copaxone for 5 yrs and used the autoinjector, but did not ever get a new autoinjector that whole time and it started malfunctioning and he did not realize it and was not getting all of the copaxone into his system, causing a relapse and hospitalization in (b)(6) 2019.

• Brand Name: AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• MDR Report Key: 9468282
• MDR Text Key: 171554761
• Report Number: MW5091671
• Device Sequence Number: 1
• Product Code: KZH
• UDI-Device Identifier: 68546032512
• UDI-Public: 68546032512
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR