MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM 10CT; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD GNM 10CT

Device Problems Device Emits Odor (1425); Scratched Material (3020)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 01/13/2020

Event Type  malfunction  

Event Description

Consumer stated the "guards have sharp edges, a bit more thicker and a stronger chemical smell.I'm noticing that my tongue is swelling up and not sure why." based on event description, may be an allergic reaction.No contact information provided, product was not returned.

• Brand Name: PLACKERS MTH GD GNM 10CT
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah stenske ; 6166988880
• MDR Report Key: 9677216
• MDR Text Key: 185530932
• Report Number: 1825660-2020-00701
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• PMA/PMN Number: K094020
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD GNM 10CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/13/2020
• Date Manufacturer Received: 01/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1