OPAQUE HERRICK LACRIMAL PLUG HP3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-10-21 for OPAQUE HERRICK LACRIMAL PLUG HP3 manufactured by Lacrimedics, Inc..

Event Text Entries

[1741055] Pt had herrick plugs inserted in left and right eye in 10/2002. Returned to dr in (b)(6) 2010 complaining of epiphora. Irrigation was not successful and pt had surgery on right lower puncta (b)(6) 2010; a herrick plug was removed.
Patient Sequence No: 1, Text Type: D, B5

[8852848] No evidence at this time that the plug was the cause of the epiphora as epiphora is still present.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2024818-2010-00001
• MDR Report Key: 1883291
• Report Source: 00
• Date Received: 2010-10-21
• Date of Report: 2010-10-21
• Date of Event: 2010-06-29
• Date Mfgr Received: 2010-08-31
• Date Added to Maude: 2011-05-04
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 434 PRUNE ALLEY PO BOX 1209
• Manufacturer City: EASTSOUND WA 98245
• Manufacturer Country: US
• Manufacturer Postal: 98245
• Manufacturer Phone: 3603767095
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OPAQUE HERRICK LACRIMAL PLUG
• Generic Name: HERRICK PLUG
• Product Code: LZU
• Date Received: 2010-10-21
• Model Number: HP3
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LACRIMEDICS, INC.
• Manufacturer Address: EASTSOUND WA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2010-10-21