Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD PROVU SINGLE USE VIDEO LARYNGOSCOPE HANDLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FLEXICARE MEDICAL DONGGUAN LTD PROVU SINGLE USE VIDEO LARYNGOSCOPE HANDLE Back to Search Results
Catalog Number 040-08-2130U
Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)
Patient Problem Insufficient Information (4580)
Event Date 01/27/2022
Event Type  malfunction  
Event Description
Event reported as 'screen froze up during mid intubation.Patient started to extubate and vomit.Patient was sent to icu afterwards'.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROVU SINGLE USE VIDEO LARYNGOSCOPE HANDLE
Type of Device
LARYNGOSCOPE
Manufacturer (Section D)
FLEXICARE MEDICAL DONGGUAN LTD
no. b-15 xicheng ind zone 1
hengli town
donnguan city, guandong 52346 0
CH  523460
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 CF454-ER
UK   CF454ER
MDR Report Key13591853
MDR Text Key286531251
Report Number3006061749-2022-00006
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number040-08-2130U
Device Lot Number210801408
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-