MAUDE Adverse Event Report: TALKING VIALS; REMINDER, MEDICATION

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Pt receives medication in talking vials; the talking vial didn't talk / was screwed up.

• Brand Name: TALKING VIALS
• Type of Device: REMINDER, MEDICATION
• MDR Report Key: 8624885
• MDR Text Key: 145783336
• Report Number: MW5086779
• Device Sequence Number: 1
• Product Code: NXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR