TRACH LIGHT WAND * 621100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-13 for TRACH LIGHT WAND * 621100 manufactured by Laerdal Medical Corp..

Event Text Entries

[68598] Difficult intubation (grade iv laryngoscopy) decision for alternative means for intubation. Trach lite used without major difficulty. Breath sounds. Co2 confirmed good ett placement. Pt coughed up tip of trach lite (plastic tip) on following day. Cxr negative, bronch negative for other particles. Trach lite wand was disposed of as is single pt use before recognized tip was off.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 112611
• MDR Report Key: 112611
• Date Received: 1997-08-13
• Date of Report: 1997-07-14
• Date of Event: 1997-07-10
• Date Facility Aware: 1997-07-11
• Report Date: 1997-07-14
• Date Reported to Mfgr: 1997-07-14
• Date Added to Maude: 1997-08-15
• 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
• Reporter Occupation: RISK MANAGER
• 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: TRACH LIGHT WAND
• Generic Name: INTUBATION DEVICE
• Product Code: FCQ
• Date Received: 1997-08-13
• Model Number: *
• Catalog Number: 621100
• Lot Number: 10959
• ID Number: STERILIZATION DATE 022296
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 110547
• Manufacturer: LAERDAL MEDICAL CORP.
• Manufacturer Address: ONE LABRIOLA COURT ARMONK NY 105040190 US
• Baseline Brand Name: TRACHLIGHT WAND
• Baseline Generic Name: LIGHTED STYLET FOR INTUB
• Baseline Model No: ADULT SINGL
• Baseline Catalog No: 621100
• Baseline ID: 510K# K922842/A

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-08-13