MAUDE Adverse Event Report: RANIR CORPORATION REST ASSURED EXTRA COMFORT

Model Number REST ASSURED

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Tachycardia (2095)

Event Date 02/12/2014

Event Type  Injury  

Event Description

You sell mouth guards.(b)(6), 2014, i bought your brand because it was cheaper.I checked the box from one side to the other making sure the guard had no latex.The box does not have any warning in the do not use if.I am severely allergic to latex and had i known the night guard contained latex i wouldn't have bought one.Using it, the roof of my mouth became like razor blades, i had trouble breathing, heart racing, swollen face, lips, lips tingled and pressure in my ears became unreal painful.I thought i had an ear infection.Thursday, (b)(6), 2014 it finally hit me, it can't be my ear.I looked on the website for the night guards and found out that these guards have latex in it.I was treating my ear when i was really reacting to the latex from having the guard in my mouth.

Manufacturer Narrative

This product does not contain latex.The device was not returned, but the lot number was given.A qa investigation will be conducted to ensure there is also no latex in the mfg process.Due to the severity of the reaction, the response is consistent with that of an allergic reaction that is not mild.Consumer may be allergic to more that just latex.Reportable event.

• Brand Name: REST ASSURED EXTRA COMFORT
• Manufacturer (Section D): RANIR CORPORATION; 4701 east paris ave. s.e.; grand rapids MI 49512
• Manufacturer (Section G): RANIR CORPORATION; 4701 east paris ave. s.e.; grand rapids MI 49512
• Manufacturer Contact: 4701 east paris ave. s.e.; grand rapids, MI 49512
• MDR Report Key: 3645152
• MDR Text Key: 4182031
• Report Number: 1825660-2014-00005
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REST ASSURED
• Device Lot Number: 060508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other