MAUDE Adverse Event Report: UNKNOWN PHARMACY SYSTEM; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

The pharmacist typed "as directed" in the system, the sigs code changed to "left ear" directed.The pharmacy system required to put a bracket ( [ ] ) in between any free text.The pharmacist forgot to put in the bracket.Transcription error/misunderstood order inaccurate information (label/labeling).(b)(6).

• Brand Name: PHARMACY SYSTEM
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19042329
• MDR Text Key: 339485631
• Report Number: MW5153538
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2024
• Patient Sequence Number: 1