MAUDE Adverse Event Report: UNKNOWN PUNCTUM PLUGS; PLUG, PUNCTUM

Device Problem Output Problem (3005)

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

Event Type  Injury  

Event Description

Lack of efficacy.

• Brand Name: PUNCTUM PLUGS
• Type of Device: PLUG, PUNCTUM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10100998
• MDR Text Key: 193398116
• Report Number: MW5094750
• Device Sequence Number: 2
• 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: Patient
• Type of Report: Initial
• Report Date: 05/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1