PLACKERS MTH GD GNM 10CT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-06 for PLACKERS MTH GD GNM 10CT manufactured by Ranir Llc.

Event Text Entries

[185530932] Consumer stated the "guards have sharp edges, a bit more thicker and a stronger chemical smell. I'm noticing that my tongue is swelling up and not sure why. " based on event description, may be an allergic reaction. No contact information provided, product was not returned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1825660-2020-00701
• MDR Report Key: 9677216
• Report Source: CONSUMER
• Date Received: 2020-02-06
• Date of Report: 2020-02-06
• Date of Event: 2020-01-13
• Date Facility Aware: 2020-01-13
• Date Mfgr Received: 2020-01-13
• Date Added to Maude: 2020-02-06
• 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 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: 3

Device Details

• Brand Name: PLACKERS MTH GD GNM 10CT
• Generic Name: MOUTHGUARD, OVER-THE-COUNTER
• Product Code: OBR
• Date Received: 2020-02-06
• Model Number: MTH GD GNM 10CT
• 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		2020-02-06