MAUDE Adverse Event Report: RANIR LLC READY TO WEAR NO BOIL NITE PROTECTOR; BRUXISM MOUTH GUARD

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 05/29/2015

Event Type  malfunction  

Event Description

After just 2 wears, the material is ripping and i ended up with pieces of the protector in my mouth.

Manufacturer Narrative

Requested return of device from consumer to visualize malfunction and to investigate root cause.Device not rec'd yet.

• Brand Name: READY TO WEAR NO BOIL NITE PROTECTOR
• Type of Device: BRUXISM MOUTH GUARD
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4884429
• MDR Text Key: 21329580
• Report Number: 1825660-2015-00068
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Device Unattended
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1