MAUDE Adverse Event Report: DANIELS HEALTH SHARPSMART

Model Number S22 REGULAR

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/12/2015

Event Type  malfunction  

Event Description

Upon patient discharge, housekeeping identified that sharps container inside the room had been forcefully opened.

• Brand Name: SHARPSMART
• Type of Device: SHARPSMART
• Manufacturer (Section D): DANIELS HEALTH; chicago IL 60604
• MDR Report Key: 5366124
• MDR Text Key: 36215890
• Report Number: MW5059290
• Device Sequence Number: 1
• Product Code: MMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S22 REGULAR
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR