BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS

    MDR report key: 17367612 · Received July 20, 2023

    Report

    Report Number
    2031532-2023-00001
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    November 16, 2022
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    LBH
    UDI-DI
    00075020034991
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DISCUS DENTAL RECEIVED A COMPLAINT ON 11/17/2022 IN WHICH OFFICE REPORTED A PATIENT HAD BLISTER AND BLEEDING ON HER THROAT AFTER ZOOM WHITENING PROCEDURE. THE EVENT OCCURRED IN THE UNITED STATES. PER OBTAINED AVAILABLE INFORMATION RECEIVED FROM DENTAL PROFESSIONAL AND CLINICAL ASSESSMENT PROVIDED ON 12/2/2022, THE COMPLAINT WAS DETERMINED NOT REPORTABLE. HOWEVER, NEW INFORMATION RECEIVED ON 7/6/23 REPORTED THE PATIENT WAS DIAGNOSED WITH VOCAL FOLD TRAUMA. THE PATIENT PRESENTED WITH BILATERAL TRUE VOCAL FOLD HEMORRHAGES WITH ACUTE LOSS OF VOICE AND VOCAL FOLD VIBRATION. PICTURES WERE PROVIDED FOR FURTHER INVESTIGATION. BATCH RECORD OF SKU #: 88105560154 LOT #: 21258013 UDI#: (B)(4) WAS REVIEWED AND NO OUT OF SPECIFICATION OR DISCREPANCIES WAS FOUND DURING THE PRODUCTION OF THIS LOT. EXPIRATION DATE: 2023-06. BATCH RECORD OF SKU #: 22-3764 LOT #: 21245031 WAS REVIEWED AND NO OUT OF SPECIFICATION OR DISCREPANCIES WAS FOUND DURING THE PRODUCTION OF THIS LOT. EXPIRATION DATE: 2023-01. CUSTOMER DID NOT RETURN THE SAMPLE FOR INVESTIGATION. RETAIN SAMPLE WERE TESTED AND LAB RESULT INDICATED THE REPORTED LOT MET THE SPECIFICATION. SKU #: 22-3764 LOT #: 21245031. PER OBTAINED INFORMATION, OFFICE USED THE LAMP EXCEEDED 5-YEARS LIFE EXPECTANCY. CLINICAL SCIENTIST REVIEWED THE PROVIDED PICTURES FROM PATIENT AND CONFIRMED THE HEMORRHAGING AT THE BACK OF THE THROAT. THE GEL HAD BURNED THE BACK OF THE THROAT BY LEAKING OR DROPPING DURING APPLICATION/OVERUSE AND FURTHER LIGHT APPLICATION WITH LACK OF ISOLATION. THE INCIDENT COULD BE OCCURRED DUE TO FORESEEABLE MISUSE AND LACK OF TRAINING OF THE DENTAL OFFICE STAFF. DFU HAVE PROVIDED SUFFICIENT INSTRUCTIONS FOR THE ISOLATION PROCEDURE. THE PROCEDURE REQUIRES DENTAL PROFESSIONAL TO ISOLATE CORRECTLY WITH ALL PROVIDED MATERIAL (COTTON ROLLS, GAUZE AND FACE BIBS). IF IT WAS ISOLATED INCORRECTLY AND GEL WAS APPLIED IN ABUNDANCE AND PROPER INSTRUCTION WASN¿T GIVEN TO THE PATIENT ON THE CHAIR, IT IS LIKELY GEL DROPPED BACK THERE UNNOTICED BY THE DP DOING THE PROCEDURE. IN ADDITION, DFU INSTRUCTED DENTAL PROFESSIONAL DURING EACH 15-MINUTE SESSION, MAKE SURE PATIENT HAS MEANS OF COMMUNICATION OR DO NOT LEAVE THE PATIENT UNATTENDED. BASED ON THE INVESTIGATION RESULT AND AVAILABLE INFORMATION, IT CONCLUDED THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. THE COMPLAINT WAS DETERMINED TO BE REPORTABLE BASED ON NEW INFORMATION RECEIVED ON 7/6/2023. NO CORRECTIVE ACTIONS ARE REQUIRED. WE WILL CONTINUE TO MONITOR FOR THE SIMILAR REPORTED ISSUE. H3 OTHER TEXT : PRODUCT NOT RETURN TO MANUFACTURER. PRODUCT WAS CONSUMED.

    Description of Event or Problem · 0

    ON JULY 6, 2023, NEW INFORMATION WAS RECEIVED. IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH VOCAL FOLD TRAUMA THAT OCCURRED IN (B)(6) 2022. THE PATIENT PRESENTED WITH BILATERAL TRUE VOCAL FOLD HEMORRHAGES WITH ACUTE LOSS OF VOICE AND VOCAL FOLD VIBRATION. THIS APPEARANCE OF THE VOCAL HEMORRHAGES SUGGESTED ACUTE TRAUMA TO THE LINING OF THE VOCAL FOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938223 PHILIPS ZOOM CHAIRSIDE KIT LBH DISCUS DENTAL, LLC 881055601540 21258013 00075020034991

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention