MAUDE Adverse Event Report: RANIR, LLC PLACKERS STOP GRINDING; NITE GUARD

Model Number NO BOIL NITE PROTECTOR

Device Problem Peeled/Delaminated (1454)

Patient Problem No Code Available (3191)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

After one night of wearing it, the plastic was peeling off/shredding; the second night she had some plastic in her mouth and is hoping she didn't swallow any, so doesn't want to wear anymore.

Manufacturer Narrative

This complaint has not been confirmed.Device not returned to manufacturer, and no lot number information was given so an evaluation cannot be performed as to the root cause or actual nature of the problem.After one night of wearing it, the plastic was peeling off/shredding; the second night she had some plastic in her mouth and is hoping she didn't swallow any, so doesn't want to wear anymore this is being reported as a possible product malfunction that could potentially result in serious injury.Medical intervention may be required if device is swallowed.

• Brand Name: PLACKERS STOP GRINDING
• Type of Device: NITE GUARD
• Manufacturer (Section D): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer (Section G): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris avenue se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4197846
• MDR Text Key: 4979386
• Report Number: 1825660-2014-00933
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NO BOIL NITE PROTECTOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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