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

Model Number MTH GD GNM 10

Device Problem Insufficient Information (3190)

Patient Problem Itching Sensation (1943)

Event Date 10/31/2016

Event Type  No Answer Provided  

Event Description

There was something that made my mouth itchy.Im allergic to playtex and wonder if any is in the plastic.

• Brand Name: PLACKERS
• 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 ; 6166980880
• MDR Report Key: 6082756
• MDR Text Key: 59291104
• Report Number: 1825660-2016-00040
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• 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: 10/31/2016
• Date Manufacturer Received: 10/31/2016
• Type of Device Usage: Initial
• Patient Sequence Number: 1