CRAWFORD LACRIMAL INTUBATION SET * 28-0185

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-19 for CRAWFORD LACRIMAL INTUBATION SET * 28-0185 manufactured by Jedmed Instrument Co..

Event Text Entries

[203730] In 1999 the pt underwent upper and lower plastic repair of right-sided canaliculi, nasal lacrimal duct probing with intubation, and infracture of the middle turbinate. Three attempts were required for crawford tube placement, as the tubes continued to break upon passage. Finally, a tube was passed successfully through the canaliculi. The pt returned to surgery for the second stage of the procedure. At that time, a piece of the lacrimal intubation set from the previous surgery was found in the canaliculi. The physician removed the retained piece of tubing at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 251817
• MDR Report Key: 251817
• Date Received: 1999-11-19
• Date of Report: 1999-10-14
• Date of Event: 1999-09-21
• Date Facility Aware: 1999-10-07
• Report Date: 1999-10-14
• Date Added to Maude: 1999-12-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRAWFORD LACRIMAL INTUBATION SET
• Generic Name: LACRIMAL INTUBATION SET
• Product Code: HNW
• Date Received: 1999-11-19
• Model Number: *
• Catalog Number: 28-0185
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 243887
• Manufacturer: JEDMED INSTRUMENT CO.
• Manufacturer Address: 5416 JEDMED CT. ST. LOUIS MO 631292217 US
• Baseline Brand Name: CRAWFORD LACRIMAL INTUBATION SET
• Baseline Generic Name: *
• Baseline Model No: *
• Baseline Catalog No: 28-0185
• Baseline ID: J-10-1

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-11-19