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

Catalog Number 19910/25

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 08/10/2016

Event Type  malfunction  

Event Description

Prior to the surgical procedure performed tonsillectomy a bioseal mouth guard was placed it tore when applied to the teeth, new device placed without issue.

• Brand Name: MOUTHGUARD ADULT
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): BIOSEAL; 167 west orangethorpe avenue; placentia, CA 92870
• MDR Report Key: 5920476
• MDR Text Key: 53694708
• Report Number: 5920476
• 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: 09/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 19910/25
• Device Lot Number: 1181
• 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 Age: 34 YR