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

Model Number MTH GD GNM 10CT

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  malfunction  

Event Description

Consumer called and asked if people have ever swallowed the grind no more guard because she can't find it in her room this morning.Consumer was not able to confirm whether or not she swallowed the guard.

• Brand Name: PLACKERS MTH GD GNM
• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 8524725
• MDR Text Key: 142516009
• Report Number: 1825660-2019-00539
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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: 04/02/2019
• Date Manufacturer Received: 04/02/2019
• 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