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

Model Number STOP GRINDING 1CT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

Consumer stated she swallowed the grind guard.She called to see if she needed to seek medical attention.She swallowed with 10 pills at the same time, she forgot the guard was in her mouth and she believes she swallowed the guard when she swallowed the pills.Age: (b)(6) years.

• Brand Name: PLACKERS STOP GRINDING
• 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: 8379883
• MDR Text Key: 138699969
• Report Number: 1825660-2019-00512
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: STOP GRINDING 1CT
• Device Lot Number: 31115
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/01/2019
• Date Manufacturer Received: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1