MAUDE Adverse Event Report: CLINICAL CHOICE, LLC ENDOSCOPIC BITE BLOCKS

Model Number CCBB-L

Device Problem Crack (1135)

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

Event Date 02/05/2021

Event Type  No Answer Provided  

Event Description

During egd (esophagogastroduodenoscopy), patient bit down and cracked device in three pieces.None swallowed.No patient harm.

• Brand Name: ENDOSCOPIC BITE BLOCKS
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): CLINICAL CHOICE, LLC; 204 muirs chapel road suite 301q; greensboro NC 27410
• MDR Report Key: 11347824
• MDR Text Key: 232547189
• Report Number: 11347824
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CCBB-L
• Device Lot Number: 4679-859874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA