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

Model Number REPAIR-IT

Device Problem Missing Value Reason (3192)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

This report is generated as a result of a 12 month retrospective analysis of previous complaints.Device not returned.

Event Description

The product is an otc denture repair kit.The customer stated that she used the product and got sores in her mouth.She was unable to eat or wear dentures.As a result she went to the emergency room (er).The patient was prescribed antibiotics and told to use mouthwash.The customer was to follow-up with a private physician 1-2 days after.The customer had used the product previously with no adverse reaction.Follow-up calls were placed by company customer service with no answer.

• Brand Name: REPAIR-IT
• Type of Device: OTC DENTURE REPAIR KIT.
• Manufacturer (Section D): MAJESTIC DRUG CO., INC.; 4996 main st. (route 42); pob 490; south fallsburg NY 12779
• Manufacturer (Section G): MAJESTIC DRUG CO.,INC.; 4996 main st. (route 42); pob 490; south fallsburg NY 12279
• Manufacturer Contact: larry fishman ; 4996 main st. (route 42); pob 490; south fallsburg, NY 12279 ; 8002380220
• MDR Report Key: 6471501
• MDR Text Key: 72417034
• Report Number: 2411564-2017-00002
• Device Sequence Number: 1
• Product Code: EBO
• UDI-Device Identifier: 00010705400913
• UDI-Public: 00010705400913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: REPAIR-IT
• Device Catalogue Number: REPAIR-IT
• Device Lot Number: 15342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE NOTED
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR