MAUDE Adverse Event Report: PUNCTAL PLUG; PLUG, PUNCTUM

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

Ineffective.(b)(6).Hcp (healthcare professional) did consent to follow up.(b)(6).

• Brand Name: PUNCTAL PLUG
• Type of Device: PLUG, PUNCTUM
• MDR Report Key: 17452589
• MDR Text Key: 320411818
• Report Number: MW5120536
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1