MAUDE Adverse Event Report: QUEST MEDICAL, INC. STENTUBE LACRIMAL INTUBATION SET, LARGE DIAMETER; LACRIMAL STENTS AND INTUBATION SETS

Model Number LIS052

Device Problem Material Fragmentation (1261)

Patient Problems Hemorrhage/Bleeding (1888); Excessive Tear Production (2235)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

Patient has had a probe and stent procedure done twice for persistent tearing, developed persistent bloody tears, not improved with steroid eye drops.Patient ultimately taken to the operating room (or) and on exploration of the lacrimal sac, there was a plastic fragment from a stent tube found in the lacrimal sac.Patient has received two sets of stents from two surgical events-one in (b)(6) 2017 and in (b)(6) 2017.Report submitted to manufacturer.Remaining stock has been removed from the or supply room as surgeon has reported that this product has had issues 'shredding.' child pulled the stents placed in (b)(6) and (b)(6) out herself.Surgeon has had discussions with company/manufacturer and they had not had any similar complaints.

• Brand Name: STENTUBE LACRIMAL INTUBATION SET, LARGE DIAMETER
• Type of Device: LACRIMAL STENTS AND INTUBATION SETS
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown pkwy; allen TX 75002
• MDR Report Key: 7841621
• MDR Text Key: 119035663
• Report Number: 7841621
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/14/2018,08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LIS052
• Device Catalogue Number: LIS052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 730 DA