MAUDE Adverse Event Report: UNKNOWN PUNCTAL PLUG; DILATOR, LACHRYMAL

Patient Problem Dry Eye(s) (1814)

Event Type  malfunction  

Event Description

On (b)(6) 2023 - schirmer's test - 4mm of wetting ou.Temporary punctal plugs placed that day.Pt says that they did not help her dry eye symptoms.Pae reported by hcp, who does not consent to follow up.(b)(6).Reference report: mw5145879.

• Brand Name: PUNCTAL PLUG
• Type of Device: DILATOR, LACHRYMAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17780448
• MDR Text Key: 324060887
• Report Number: MW5145878
• Device Sequence Number: 1
• Product Code: HNW
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Patient Sequence Number: 1