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

Model Number	REPAIR-IT
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/20/2016
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.
Event or Problem 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
• Common Device Name: OTC DENTURE REPAIR KIT.
• Manufacturer (Section D): MAJESTIC DRUG CO., INC.; 4996 main st. (route 42); pob 490; south fallsburg NY 12779
• MDR Report Key: 6471501
• Report Number: 2411564-2017-00002
• Device Sequence Number: 1198448
• Product Code: EBO
• UDI-Device Identifier: 00010705400913
• UDI-Public: 00010705400913
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• 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: REPAIR-IT
• Device Catalogue Number: REPAIR-IT
• Device Lot Number: 15342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2016
• 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 NOTED
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 52 YR