• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYAD MEDICAL SOURCING, LLC HCS DEPRESSOR, TONGUE, NON-SURGICAL

  • 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
 

DYAD MEDICAL SOURCING, LLC HCS DEPRESSOR, TONGUE, NON-SURGICAL Back to Search Results
Model Number HCS2000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2020
Event Type  Injury  
Event Description
Laryngeal mask airway (lma) initially passed easily with use of tongue depressor. Unable to get adequate seal and difficulty ventilating noted. Lma pulled and video laryngoscopy revealed broken portion of tongue depressor seen atop epiglottis. Piece removed with magill forceps and size 7 endotracheal tube passed easily.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHCS
Type of DeviceDEPRESSOR, TONGUE, NON-SURGICAL
Manufacturer (Section D)
DYAD MEDICAL SOURCING, LLC
2101 waukegan rd ste 208
bannockburn IL 60015
MDR Report Key10471100
MDR Text Key204921392
Report Number10471100
Device Sequence Number1
Product Code FMA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHCS2000
Device Lot Number190518
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2020
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer08/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/31/2020 Patient Sequence Number: 1
-
-