MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD. BRITEPRO OMNI SINGLE USE LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID

Model Number	BRITEPRO MAC 2
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Britepro omni sterile single use laryngoscope handle (mac2) with batteries and fitted blade - light does not work.Britepro light failed.Fda safety report id # (b)(4).

• Brand Name: BRITEPRO OMNI SINGLE USE LARYNGOSCOPE HANDLE
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD.; mountain ash, mid glamorgan ; UK
• MDR Report Key: 14167858
• Report Number: MW5109208
• Device Sequence Number: 17714865
• Product Code: CCW
• UDI-Device Identifier: 05055788768838
• UDI-Public: (01)05055788768838(17)241001(10)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BRITEPRO MAC 2
• Device Catalogue Number: 040-04-0120U
• Device Lot Number: 191101795
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown