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

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.

• Brand Name: HCS
• Type of Device: DEPRESSOR, TONGUE, NON-SURGICAL
• Manufacturer (Section D): DYAD MEDICAL SOURCING, LLC; 2101 waukegan rd ste 208; bannockburn IL 60015
• MDR Report Key: 10471100
• MDR Text Key: 204921392
• Report Number: 10471100
• Device Sequence Number: 1
• Product Code: FMA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• 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 Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HCS2000
• Device Lot Number: 190518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25915 DA
• Patient Weight: 92