MAUDE Adverse Event Report: RANIR, LLC GRIND NO MORE; NITE GUARD OTC

Model Number GRIND NO MORE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Irritation (1941); Reaction (2414)

Event Date 08/19/2014

Event Type  Injury  

Event Description

"i purchased your bite guard.I am in an allergy clinic the next couple days and i am allergic to that and they can fix the allergy.Can you tell me if that's plastic or nylon or what material it's made out of? i need to know that." consumer further stated that the guard is causing irritation and infection to her gums which is not going away.She went to the allergy clinic and was told it is mostly a reaction to the material.She wore it for months before infection/irritation occurred and she soaks them in peroxide every day for cleaning/maintenance.She is allergic to nylon and will be going back to the allergy clinic once she knows that material for testing.

Manufacturer Narrative

This is being reported as an alleged allergic response.Medical intervention may be required if the device contains sensitizing material.

• Brand Name: GRIND NO MORE
• Type of Device: NITE GUARD OTC
• Manufacturer (Section D): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer (Section G): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris avenue se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4101436
• MDR Text Key: 4716828
• Report Number: 1825660-2014-00913
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: GRIND NO MORE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2014
• 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): Hospitalization