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

Catalog Number 040-309U

Device Problem Insufficient Information (3190)

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

Event Date 09/03/2022

Event Type  malfunction  

Event Description

The description of the problem as reported in medwatch 'device malfunction - that is, the device did not do what it was supposed to do'.

• 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, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 15924518
• MDR Text Key: 307929092
• Report Number: 3006061749-2022-00025
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• 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 Number: 040-309U
• Device Lot Number: 200604126
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 4500440000-2022-8046
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Sex: Female
• Patient Weight: 3 KG