MAUDE Adverse Event Report: HEALTHBEACON HEALTHBEACON SMART SHARPS BIN; CONTAINER, SHARPS

Model Number 3.0

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  Injury  

Event Description

Companion us app showed the injection due on (b)(6) 2024.Patient injected on (b)(6) 2024, a week early.Patient didn't mention any side effects on call 03-mar-2024.

• Brand Name: HEALTHBEACON SMART SHARPS BIN
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): HEALTHBEACON
• MDR Report Key: 18857164
• MDR Text Key: 337263274
• Report Number: MW5152445
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3.0
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female