BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA SIN SABOR

    MDR report key: 6066732 · Received October 31, 2016

    Report

    Report Number
    3003721894-2016-00265
    Event Type
    Injury
    Date Received
    October 31, 2016
    Report Date
    October 20, 2016
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), COREGA SIN SABOR. COREGA SIN SABOR IS MARKETED AS SUPER POLIGRIP IN THE US. QA RESULTS: SUMMARY OF INVESTIGATION: NO PREVIOUS COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED FOR THIS BATCH. THE BATCH DOCUMENTATION SPECIFIC TO THIS LOT WAS REVIEWED AND THERE WERE NO ISSUES NOTED DURING THE MANUFACTURE OF THIS BATCH THAT COULD HAVE ATTRIBUTED TO THIS DEFECT. THE COMPLAINT SAMPLE WAS SENT TO THE LAB FOR ANALYSIS, SEE RESULTS BELOW: DESCRIPTION (C-5012_1.1), SPECIFICATION: OFF-WHITE TO BEIGE MASS OF GUMS AND PETROLATUM, FREE OF LUMPS, GRANULAR PARTICLES OR FOREIGN MATTER. RESULT: COMPLIES. PH (420N-010C), SPECIFICATION: 6.5 - 7.5. RESULT: 6.7. %GANTREZ (420-4000(1.0)), SPECIFICATION: 25.5% - 34.5%. RESULT: 29.7%. TESTING WAS CARRIED OUT ON THE COMPLAINT SAMPLE AND RESULTS MET SPECIFICATION REQUIREMENTS INDICATING THAT THE PRODUCT WAS MANUFACTURED APPROPRIATELY AND COMPLIED WITH THE REQUIRED QUALITY STANDARDS. PRIOR TO RELEASE OF THE PRODUCT FROM THE SITE, THE BATCH DOCUMENTATION WAS REVIEWED BY THE QUALITY DEPARTMENT, VERIFYING THAT ALL RESULTS MET SPECIFICATION REQUIREMENTS. CONCLUSION: PLEASE BE ASSURED THAT THIS COMPLAINT HAS BEEN LOGGED, WILL BE INDICATED IN THE MANUFACTURING SITE METRICS AND ALL BE BROUGHT TO THE ATTENTION OF ALL RELEVANT SITE PERSONNEL AS PART OF THE MONTHLY COMPLAINT REVIEW PROCESS. ON THE BASIS OF THE ABOVE I NOW WISH TO CONSIDER THIS COMPLAINT CLOSED PLEASE REVERT SHOULD YOU REQUIRE ANY FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    3003721894-2016-00265 IS ASSOCIATED WITH (B)(4), COREGA SIN SABOR. COREGA SIN SABOR IS MARKETED AS SUPER POLIGRIP IN THE US.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF PALATAL LESION IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (COREGA SIN SABOR) CREAM FOR DENTURE WEARER. CO-SUSPECT PRODUCTS INCLUDED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) ORAL POWDER FOR DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA SIN SABOR AND COREGA. IN 2016, AN UNKNOWN TIME AFTER STARTING COREGA SIN SABOR AND COREGA, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE AND PRODUCT COMPLAINT. IN (B)(6) 2016, THE PATIENT EXPERIENCED PALATAL LESION (SERIOUS CRITERIA CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT AVAILABILITY ISSUE. THE PATIENT WAS TREATED WITH BENZOCAINE. ON AN UNKNOWN DATE, THE OUTCOME OF THE PALATAL LESION, DEVICE INEFFECTIVE, PRODUCT COMPLAINT AND PRODUCT AVAILABILITY ISSUE WERE UNKNOWN. THE REPORTER CONSIDERED THE PALATAL LESION TO BE RELATED TO COREGA SIN SABOR. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEVICE INEFFECTIVE AND PRODUCT COMPLAINT TO BE RELATED TO COREGA SIN SABOR. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PRODUCT AVAILABILITY ISSUE TO BE RELATED TO COREGA. ADDITIONAL DETAILS: THE CONSUMER INFORMED THAT SHE STARTED TO USE COREGA POWDER SINCE 3 MONTHS AGO BUT SHE COULD NOT FIND THE PRODUCT IN THE MARKET, AND FOR THIS REASON STARTED USING COREGA CREAM WITHOUT FLAVOUR (START DATE UNKNOWN) BUT THIS PRODUCT DID NOT HAVE EFFICACY OF FIXING AND DID NOT FIX THE DENTAL PROSTHESIS. THE CONSUMER INFORMED THAT THE DENTAL PROSTHESIS WAS NEW AND SHE VISITED HER DENTIST 3 TIMES. THE DENTIST REVIEWED DENTAL PROSTHESIS AND HE INFORMED THAT THE PROTHESIS DID NOT HAVE PROBLEM. THE CONSUMER INFORMED THAT SHE EXPERIENCED PALATE INJURIES SINCE 1 WEEK AGO, BECAUSE PROSTHESIS DOES NOT FIX AND FOR THIS REASON SHE WAS USING BENZOCAINE. THE CASE WAS SENT TO CONSUMER HEALTHCARE QUALITY ASSURANCE. FOLLOW UP INFORMATION RECEIVED 04 NOVEMBER 2016 COREGA SIN SABOR CREAM (BATCH NUMBER (B)(4)). THE PRODUCT COMPLAINT IS UNSUBSTANTIATED. COREGA SIN SABOR WAS CONTINUED WITH NO CHANGE.

    Description of Event or Problem · 1

    PALATE INJURIES [PALATAL LESION]; LACK OF EFFICACY / DOES NOT FIX THE DENTAL PROSTHESIS [DEVICE INEFFECTIVE]; LACK OF EFFICACY / DOES NOT FIX THE DENTAL PROSTHESIS [PRODUCT COMPLAINT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF PALATAL LESION IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (COREGA SIN SABOR) CREAM FOR DENTURE WEARER. CO-SUSPECT PRODUCTS INCLUDED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) ORAL POWDER FOR DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA SIN SABOR AND COREGA. IN 2016, AN UNKNOWN TIME AFTER STARTING COREGA SIN SABOR AND COREGA, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE AND PRODUCT COMPLAINT. IN (B)(6) 2016, THE PATIENT EXPERIENCED PALATAL LESION (SERIOUS CRITERIA CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT AVAILABILITY ISSUE. THE PATIENT WAS TREATED WITH BENZOCAINE. ON AN UNKNOWN DATE, THE OUTCOME OF THE PALATAL LESION, DEVICE INEFFECTIVE, PRODUCT COMPLAINT AND PRODUCT AVAILABILITY ISSUE WERE UNKNOWN. THE REPORTER CONSIDERED THE PALATAL LESION TO BE RELATED TO COREGA SIN SABOR. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEVICE INEFFECTIVE AND PRODUCT COMPLAINT TO BE RELATED TO COREGA SIN SABOR. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PRODUCT AVAILABILITY ISSUE TO BE RELATED TO COREGA. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE CONSUMER INFORMED THAT SHE STARTED TO USE COREGA POWDER SINCE 3 MONTHS AGO BUT SHE COULD NOT FIND THE PRODUCT IN THE MARKET, AND FOR THIS REASON STARTED USING COREGA CREAM WITHOUT FLAVOUR (START DATE UNKNOWN) BUT THIS PRODUCT DID NOT HAVE EFFICACY OF FIXING AND DID NOT FIX THE DENTAL PROSTHESIS. THE CONSUMER INFORMED THAT THE DENTAL PROSTHESIS WAS NEW AND SHE VISITED HER DENTIST 3 TIMES. THE DENTIST REVIEWED DENTAL PROSTHESIS AND HE INFORMED THAT THE PROTHESIS DID NOT HAVE PROBLEM. THE CONSUMER INFORMED THAT SHE EXPERIENCED PALATE INJURIES SINCE 1 WEEK AGO, BECAUSE PROSTHESIS DOES NOT FIX AND FOR THIS REASON SHE WAS USING BENZOCAINE. THE CASE WAS SENT TO CONSUMER HEALTHCARE QUALITY ASSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719161 COREGA SIN SABOR DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD UL4B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention