BULLARD * LAR-AE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-02 for BULLARD * LAR-AE manufactured by Acmi Corp.

Event Text Entries

[16476972] Pt with h/o difficult endotracheal intubation was successfully intubated for cabg with the use of a bullard laryngoscope, employing manufacturer's plastic extension tip to facilitate intubation procedure. Post surgery, pt c/o gastric reflux symptoms -consistent with h/o gerd- and was treated medically. Symptoms continued post d/c four days later and eventually necessitated endoscopic exam, which revealed a foreign body in the esophagus. Pt was re-admitted 2 weeks later for removal of foreign body, which was found to be the plastic tip extender from the bullard laryngoscope. No injury to the esophagus was noted and pt was d/c'd the following day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032895
• MDR Report Key: 549865
• Date Received: 2004-08-02
• Date of Report: 2004-08-02
• Date of Event: 2004-06-28
• Date Added to Maude: 2004-10-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BULLARD
• Generic Name: ADULT LARYNGOSCOPE BLADE EXTENDER
• Product Code: EQN
• Date Received: 2004-08-02
• Model Number: *
• Catalog Number: LAR-AE
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 539384
• Manufacturer: ACMI CORP
• Manufacturer Address: 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US
• Baseline Brand Name: BULLARD LARYNGOSCOPE BLADE EXTENDER FOR ADULT
• Baseline Generic Name: BLADE EXTENDER
• Baseline Model No: LAR-AE
• Baseline Catalog No: LAR-AE
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-08-02