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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO MINI; LARYNGOSCOPE

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FLEXICARE MEDICAL LTD BRITEPRO SOLO MINI; LARYNGOSCOPE Back to Search Results
Catalog Number 040-310U, 040-309U
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/14/2022
Event Type  malfunction  
Manufacturer Narrative
Flexicare has reached out to the hospital, to gain clarity on what they are calling a plastic blade.This was also the same clinic involved with medwatch 263302222-2022-8016.The blade size was unknown.Flexicare was advised the patient was not harmed by intubation and no adverse event took place.
 
Event Description
The description of the problem as reported in medwatch 'device was hard to use.'.
 
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Brand Name
BRITEPRO SOLO MINI
Type of Device
LARYNGOSCOPE
Manufacturer (Section D)
FLEXICARE MEDICAL LTD
cynon valley business park
mountain ash, CF45 4ER
UK  CF45 4ER
Manufacturer (Section G)
FLEXICARE MEDICAL DONGGUAN
no. b-15 xicheng ind zone 1
hengli town
dongguan city, gunagdong 52346 0
CH   523460
Manufacturer Contact
julie davies
cynon valley business park
mountain ash, rct CF45 -4ER
UK   CF45 4ER
MDR Report Key15924520
MDR Text Key307929147
Report Number3006061749-2022-00024
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/06/2022
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 Catalogue Number040-310U, 040-309U
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/08/2022
Initial Date FDA Received12/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2633020000-2022-8015
Patient Sequence Number1
Patient Age1 MO
Patient SexMale
Patient Weight3 KG
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