MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL MEROCEL WIPE AND WICK AND CORNEAL LIGHTSHIELD

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2015

Event Type  Other  

Event Description

Prod was used as unintended.Plan was to use gelfoam and suture pt closed with f/u days later with removal."wipe with wick and corneal light shield" was implanted accidentally due to similarities in appearance.Reason for use: normal use is an instrument wipe, was implanted instead.

• Brand Name: MEROCEL WIPE AND WICK AND CORNEAL LIGHTSHIELD
• Type of Device: MEROCEL WIPE AND WICK AND CORNEAL LIGHTSHIELD
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL
• MDR Report Key: 4850293
• MDR Text Key: 18883136
• Report Number: MW5043100
• Device Sequence Number: 1
• Product Code: MDM
• 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: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Weight: 8