FDA Adverse Event Malfunction Summary report: N

BRITEPRO SOLO STUBBY

MDR report key: 19943244 · Received August 8, 2024

Report

Report Number
3006061749-2024-00030
Event Type
Malfunction
Date Received
August 8, 2024
Date of Event
July 9, 2024
Report Date
July 9, 2024
Manufacturer
FLEXICARE MEDICAL LTD
Product Code
CCW
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

UDI INFORMATION IS NOT AVAVILBE AT THE TIME OF THIS SUBMISSION.

Description of Event or Problem · 0

DETAILS OF THE EVENT AS TOLD TO MANUFACTURER 'DURING INTUBATION THE CAP AT THE END DISCONNECTED AND THE USER LOST THEIR VIEW BECAUSE THE LIGHT WENT OUT'

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1065947 BRITEPRO SOLO STUBBY LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD 231201803

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown