MAUDE Adverse Event Report: BIOSEAL MOUTH GUARD ADULT; MOUTHGUARD, OVER-THE-COUNTER

Catalog Number 19910/25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/05/2016

Event Type  malfunction  

Event Description

Surgical procedure performed micro direct laryngoscopy with excision of laryngeal mass with bioseal mouth guard placed to upper teeth - patient intubated with out issue, mouth guard placed for the laryngoscopy procedure.Upon completion of the procedure, the mouth guard taken off prior to extubation it was discovered the patient's two top front teeth were chipped and rough - new finding - no issues with teeth preoperatively.

• Brand Name: MOUTH GUARD ADULT
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): BIOSEAL; 167 west orangethorpe avenue; placentia CA 92870
• MDR Report Key: 5924296
• MDR Text Key: 53800046
• Report Number: 5924296
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 19910/25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2016
• Event Location: Other
• Date Report to Manufacturer: 08/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR