LACRICATH 2.0MM LDC213 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-04-16 for LACRICATH 2.0MM LDC213 * manufactured by Quest Medical, Inc..

Event Text Entries

[304718] The customer reported that two catheters would not connect to the inflator. The pt was already anesthetized. The third catheter worked.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1649914-2003-00021
• MDR Report Key: 454910
• Report Source: 05,06
• Date Received: 2003-04-16
• Date of Report: 2003-04-16
• Date of Event: 2003-03-06
• Date Mfgr Received: 2003-03-06
• Date Added to Maude: 2003-04-23
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: KATHRYN THOMPSON
• Manufacturer Street: ONE ALLENTOWN PKWY
• Manufacturer City: ALLEN TX 75002
• Manufacturer Country: US
• Manufacturer Postal: 75002
• Manufacturer Phone: 9723909800
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LACRICATH 2.0MM
• Generic Name: LACRIMAL DUCT BALLOON CATHETER
• Product Code: HNW
• Date Received: 2003-04-16
• Model Number: LDC213
• Catalog Number: *
• Lot Number: AM052802-1
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 443907
• Manufacturer: QUEST MEDICAL, INC.
• Manufacturer Address: ONE ALLENTOWN PKWY. ALLEN TX 75002 US
• Baseline Brand Name: LACRICATH 2.0MM
• Baseline Generic Name: LACRIMAL DUCT BALLOON CATHETER
• Baseline Model No: LDC213
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-04-16