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

Model Number MTH GD RST ASRD W/TRAY 2CT CD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

Product not found and complainant would not respond to several phone calls to see if they recovered the device.Complainant was contacted several times after reporting the possible swallowing of device to see if the device was recovered or if they found the device in bedding or on floor.Complainant did not respond to our calls.Ranir quality believes that it's highly unlikely that the device could have been swallowed during sleep without the complainant experiencing some reaction (gagging) or awakening.The device is large and firm and not easily swallowed.

Event Description

Reporter's wife purchased a rest assured dental protector."she apparently swallowed it last night, we were looking for information on how to locate it on the xray.".

Manufacturer Narrative

Added more information to describe event or problem.Product not found and complainant would not respond to several phone calls to see if they recovered the device.Complainant was contacted several times after reporting the possible swallowing of device to see if the device was recovered or if they found the device in bedding or on floor.Complainant did not respond to our calls.Ranir quality believes that it's highly unlikely that the device could have been swallowed during sleep without the complainant experiencing some reaction (gagging) or awakening.The device is large and firm and not easily swallowed.

Event Description

Reporter's wife purchased a rest assured dental protector."she apparently swallowed it last night, we were looking for information on how to locate it on the xray.".

• Brand Name: EQUATE
• 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: 6684243
• MDR Text Key: 79126450
• Report Number: 1825660-2017-00114
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• PMA/PMN Number: K133423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2017
• Date Manufacturer Received: 06/12/2017
• 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