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

Model Number MTH GD GNM 10

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/29/2016

Event Type  Injury  

Event Description

I swallowed a grind-no-more in my sleep last night.

• Brand Name: PLACKERS
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49506
• 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: 6264657
• MDR Text Key: 65345563
• Report Number: 1825660-2017-00045
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• 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: 12/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: MTH GD GNM 10
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/29/2016
• Date Manufacturer Received: 12/29/2016
• Type of Device Usage: Unknown
• Patient Sequence Number: 1