MAUDE Adverse Event Report: FLEXICARE BRITE PRO SOLO; LARYNGOSCOPE

Model Number 040-333U

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 06/02/2014

Event Type  Injury  

Event Description

Patient intubated with brits pro solo laryngoscope and sustained airway injury necessitating sutures.

• Brand Name: BRITE PRO SOLO
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE; 15281 barranca pkwy.; 92618
• MDR Report Key: 4080796
• MDR Text Key: 4827231
• Report Number: MW5038111
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 040-333U
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR