REPAIR-IT
Received Apr 7, 2017 · Event occurred Jun 20, 2016
Report 2411564-2017-00002 · MDR key 6471501
Device
Generic name
Otc Denture Repair Kit.
Manufacturer
Majestic Drug Co., Inc.Model number
REPAIR-ITCatalog number
REPAIR-IT
Lot number
15342
Product problems
- Missing Value Reason
- Missing Value Reason
Patient
52 YR
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
THIS REPORT IS GENERATED AS A RESULT OF A 12 MONTH RETROSPECTIVE ANALYSIS OF PREVIOUS COMPLAINTS. DEVICE NOT RETURNED.
Description of Event or Problem
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.
Remedial action
- Replace