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

Device Problem Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the pt called in for having only received a partial dose due to an error with the autoinjector device.

• Brand Name: AUTOINJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): OWEN MUMFORD USA INC.
• MDR Report Key: 8479865
• MDR Text Key: 140965086
• Report Number: MW5085559
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• 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?: Yes
• Patient Sequence Number: 1
• Patient Age: 33 YR