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

Model Number BRITEPRO MAC 2

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Event 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
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD.; mountain ash, mid glamorgan ; UK
• MDR Report Key: 14167858
• MDR Text Key: 289893447
• Report Number: MW5109208
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 05055788768838
• UDI-Public: (01)05055788768838(17)241001(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1