BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR. BEST ZWISCHENZAHN MEDIUM

    MDR report key: 11893638 · Received May 27, 2021

    Report

    Report Number
    9615008-2021-00008
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    April 29, 2021
    Report Date
    April 29, 2021
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF FOREIGN BODY IN THROAT IN A 77-YEAR-OLD FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (DR. BEST ZWISCHENZAHN MEDIUM) TOOTHBRUSH (BATCH NUMBER M43027000, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON (B)(6) 2021, THE PATIENT STARTED DR. BEST ZWISCHENZAHN MEDIUM. ON (B)(6) 2021, 21 DAYS AFTER STARTING DR. BEST ZWISCHENZAHN MEDIUM, THE PATIENT EXPERIENCED FOREIGN BODY IN THROAT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT. DR. BEST ZWISCHENZAHN MEDIUM WAS DISCONTINUED ON 29TH APRIL 2021 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE FOREIGN BODY IN THROAT, FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FOREIGN BODY IN THROAT AND FOREIGN BODY IN MOUTH TO BE RELATED TO DR. BEST ZWISCHENZAHN MEDIUM.. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION RECEIVED FROM THE CONSUMER VIA CALL CENTER REPRESENTATIVE ON (B)(6) 2021. CONSUMER REPORTED THAT, "FOR DR.BEST ZWISCHENZAHN MITTEL (MEDIUM), THAT THERE IS A BLACK THREAD IN THE TOOTHBRUSH AND WHEN BRUSHING THE TEETH THAT IT HAS REMAINED BETWEEN THE TEETH, AND THIS MORNING WHEN BRUSHING TEETH THE THREAD STUCK IN THE THROAT". PQC INFORMATION: NAME OF PRODUCT QUALITY COMPLAINT: (B)(4). LEVEL 2 REASON CODE: PROD CHARACTERISTICS COMPLAINT. LEVEL 3 REASON CODE: TOOTHBRUSH LOOSES OR IS MISSING FILAMENTS OR TUFTS - CPC LOOSE BRIST. PQC STATUS: AWAITING TRIAGE. COMPLAINT CONCLUSION: PQC EVALUATION: RESPONSE TO CONSUMER: CASE NUMBER OF RELATED CASE IN PQC TYPE: (B)(4). FOLLOW UP INFORMATION RECEIVED ON 12 MAY 2021 FROM QUALITY ASSURANCE DEPARTMENT REGARDING COMPLAINT NO. (B)(4) (ISSUE NO.). THE INVESTIGATION REPORTS CONCLUDED THAT, THE COMPLAINT STANDS UNSUBSTANTIATED. THE REVIEW OF MANUFACTURING / PACKAGING BATCH RECORDS DID NOT INDICATE THAT THIS COMPLAINT MAY BE DUE TO A PROCESSING PROBLEM. A TREND ANALYSIS WITH SAME PRODUCT OF COMPLAINT SUBJECT SHOWS NO ABNORMALITIES. NO RECALL HAS BEEN STARTED BY THIS ARTICLE. FURTHER INVESTIGATION IS NOT POSSIBLE WITHOUT RECEIVING THE COMPLAINT SAMPLE. THIS COMPLAINT HAS BEEN LOGGED AND WILL BE EVALUATED AND PRESENT IN THE MONTHLY COMPLAINT REVIEW PROCESS. ON THE BASIS OF THE ABOVE THE COMPLAINT IS CONSIDERED AS CLOSED. WITH THE RECEIPT OF THE PHOTO / VIDEO OR COMPLAINT SAMPLE, THE COMPLAINT WILL BE RE-OPENED AND FURTHER INVESTIGATION CARRIED OUT AS REQUIRED. A FINAL REPORT WILL BE ISSUED IN ACCORDANCE WITH THE QUALITY AGREEMENT WITHIN 30 DAYS AFTER RECEIVING THE COMPLAINT SAMPLE. NO MANUFACTURING ERROR HAS BEEN DETECTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BLACK THREAD IN THE TOOTHBRUSH AND WHEN BRUSHING THE TEETH THAT IT HAS REMAINED BETWEEN THE TEETH, AND THIS MORNING WHEN BRUSHING TEETH THE THREAD STUCK IN THE THROAT [FOREIGN BODY IN THROAT]. BLACK THREAD IN THE TOOTHBRUSH AND WHEN BRUSHING THE TEETH THAT IT HAS REMAINED BETWEEN THE TEETH [FOREIGN BODY IN MOUTH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF FOREIGN BODY IN THROAT IN A (B)(6) FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (DR. BEST ZWISCHENZAHN MEDIUM) TOOTHBRUSH (BATCH NUMBER M43027000, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON (B)(6) 2021, THE PATIENT STARTED DR. BEST ZWISCHENZAHN MEDIUM. ON (B)(6) 2021, 21 DAYS AFTER STARTING DR. BEST ZWISCHENZAHN MEDIUM, THE PATIENT EXPERIENCED FOREIGN BODY IN THROAT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT. DR. BEST ZWISCHENZAHN MEDIUM WAS DISCONTINUED ON (B)(6) 2021 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE FOREIGN BODY IN THROAT, FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FOREIGN BODY IN THROAT AND FOREIGN BODY IN MOUTH TO BE RELATED TO DR. BEST ZWISCHENZAHN MEDIUM.. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION RECEIVED FROM THE CONSUMER VIA CALL CENTER REPRESENTATIVE ON (B)(6) 2021. CONSUMER REPORTED THAT, "FOR DR.BEST ZWISCHENZAHN MITTEL (MEDIUM), THAT THERE IS A BLACK THREAD IN THE TOOTHBRUSH AND WHEN BRUSHING THE TEETH THAT IT HAS REMAINED BETWEEN THE TEETH, AND THIS MORNING WHEN BRUSHING TEETH THE THREAD STUCK IN THE THROAT". PQC INFORMATION: NAME OF PRODUCT QUALITY COMPLAINT: (B)(4). LEVEL 2 REASON CODE: PROD CHARACTERISTICS COMPLAINT. LEVEL 3 REASON CODE: TOOTHBRUSH LOOSES OR IS MISSING FILAMENTS OR TUFTS - CPC LOOSE BRIST. PQC STATUS: AWAITING TRIAGE. COMPLAINT CONCLUSION: PQC EVALUATION: RESPONSE TO CONSUMER: CASE NUMBER OF RELATED CASE IN PQC TYPE: (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790540 DR. BEST ZWISCHENZAHN MEDIUM TOOTHBRUSHES EFW M43027000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other