MAUDE Adverse Event Report: MAJESTIC DRUG CO., INC. RELINE-IT; OTC DENTURE RELINER

Model Number	RELINE-IT
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is generated as a result of a 12 month retrospective analysis of previous complaints.Device not returned for evaluation, product replaced to customer (b)(6) 2016.
Event or Problem Description
The product is an otc denture reliner.The exact age and weight of the customer is not known.The customer has used the product several times before as indicated on his e-mail communication.In this instance the customer complained of a burn on the roof of his mouth and resulting pain the morning after.As a result he was not able to eat for 2 days or wear his partial appliance.The company replaced the product to the customer on (b)(6) 2016.The customer has not advised the company of any further discomfort or pain.No medical intervention was required.

• Brand Name: RELINE-IT
• Common Device Name: OTC DENTURE RELINER
• Manufacturer (Section D): MAJESTIC DRUG CO., INC.; 4996 main st., route 42; pob 490; south fallsburg NY 12779
• MDR Report Key: 6471495
• Report Number: 2411564-2017-00001
• Device Sequence Number: 16295035
• Product Code: EBP
• UDI-Device Identifier: 00010705400968
• UDI-Public: 00010705400968
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RELINE-IT
• Device Catalogue Number: RELINE-IT
• Device Lot Number: 16123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2016
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE KNOWN
• Outcome Attributed to Adverse Event: Other