MAUDE Adverse Event Report: FLEXICARE INC BRITEPRO SOLO; LARYNGOSCOPE, RIGID

Model Number 040-344U

Device Problem Inadequate Lighting (2957)

Patient Problem No Information (3190)

Event Date 09/20/2016

Event Type  malfunction  

Event Description

After assembly - the light is not bright enough.

• Brand Name: BRITEPRO SOLO
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE INC; ashley motamedi; 15281 barranca parkway unit d; irvine CA 92618
• MDR Report Key: 6031145
• MDR Text Key: 57491567
• Report Number: 6031145
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 11/30/2018
• Device Model Number: 040-344U
• Device Lot Number: 131100879
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2016
• Device Age: 1 DY
• Event Location: Other
• Date Report to Manufacturer: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO