RITE AID REST ASSURED NITE REST ASSURED NITE PROTECT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for RITE AID REST ASSURED NITE REST ASSURED NITE PROTECT manufactured by Ranir Llc.

Event Text Entries

[142907048] Consumer stated the blue part separated from the other part. He had the product for a long time and just tried to fit it.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1825660-2019-00543
• MDR Report Key: 8535845
• Date Received: 2019-04-22
• Date of Report: 2019-04-22
• Date of Event: 2019-04-01
• Date Facility Aware: 2019-04-03
• Date Mfgr Received: 2019-04-03
• Date Added to Maude: 2019-04-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: REBEKAH STENSKE
• Manufacturer Street: 4701 EAST PARIS AVE. SE
• Manufacturer City: GRAND RAPIDS MI 495125353
• Manufacturer Country: US
• Manufacturer Postal: 495125353
• Manufacturer Phone: 6166988880
• Manufacturer G1: RANIR LLC
• Manufacturer Street: 4701 EAST PARIS AVE. SE
• Manufacturer City: GRAND RAPIDS MI 495125353
• Manufacturer Country: US
• Manufacturer Postal Code: 495125353
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: RITE AID REST ASSURED NITE
• Generic Name: MOUTHGUARD, OVER-THE-COUNTER
• Product Code: OBR
• Date Received: 2019-04-22
• Model Number: REST ASSURED NITE PROTECT
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RANIR LLC
• Manufacturer Address: 4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-22