BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRRCHGTOOTHBRUSHHANDLEPROCROSSACTN

    MDR report key: 6233197 · Received January 9, 2017

    Report

    Report Number
    3000302531-2017-00015
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Report Date
    December 12, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER, THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF THE RETURNED PRODUCT.

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER, THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    CASE DESCRIPTION: A WIFE REPORTED VIA E-MAIL ON 12-DEC-2016 THAT WHEN HER HUSBAND, AGE UNSPECIFIED, PULLED AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN FROM HIS MOUTH ON AN UNSPECIFIED DATE, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN CAME SEPARATED FROM THE UNIT AND THE POINTED END STABBED HIM IN THE CHEEK. THE REPORTER STATED IT PIERCED THE SKIN AND DREW BLOOD. THE CASE OUTCOME WAS UNKNOWN. 16-DEC-2016 RECEIVED REPORTER'S FOLLOW-UP E-MAIL: THE WIFE REPORTED THAT HER HUSBAND USED AN ORAL-B PRO 600 RECHARGEABLE TOOTHBRUSH WITH AN ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN FROM A PACK OF 3. HE CHANGED HIS TOOTHBRUSH HEAD ABOUT EVERY 4 MONTHS, BUT THE REFILL HE HAD USED WAS NOT THAT OLD. SHE REPORTED THE BRUSH HAS NEVER BEEN DROPPED BUT MAY HAVE FALLEN FROM UPRIGHT. THE CASE OUTCOME REMAINED UNKNOWN. 14-JUN-2017 RECEIVED CONSUMER'S FOLLOW-UP E-MAIL: THE CONSUMER REPORTED THAT FOR THE SECOND TIME NOW, A BRUSH HEAD CAME OFF THE BRUSH IN HIS MOUTH WHILE BRUSHING HIS TEETH THAT MORNING, WHICH LED TO THE PIN THAT HOLDS THE HEAD ON STABBING HIM IN THE FACE. HE REPORTED THE FIRST TIME IT PUNCTURED HIS CHEEK, AND THIS TIME IT REMOVED A HUGE CHUNK OF SKIN FROM INSIDE HIS NOSE. HE REPORTED THERE WAS A LOT OF BLOOD, AND HIS NOSE WAS EXTREMELY SORE NOW. THE CONSUMER REPORTED THE CURRENT BRUSH HE HAD WAS AN ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE PRO CROSSACTION (PRO 4000). THE CONSUMER STATED THE BRUSH HEADS WERE REPLACEMENT HEADS FROM THE FIRST TIME THIS HAPPENED, AND THE VERSION OF BRUSH HEAD WAS NOT REPORTED. THE OUTCOME OF BLEEDING WAS RECOVERED. THE OUTCOMES OF THE STABBING FACE, REMOVED CHUNK OF SKIN FROM INSIDE NOSE, AND NOSE SORE WERE NOT RECOVERED/NOT RESOLVED. THE CASE OUTCOME WAS IMPROVED. TREATMENT DETAILS: UNKNOWN. THE CONSUMER REPORTED HE HAD USED ORAL-B PRODUCTS FOR OVER 10 YEARS. CONCOMITANT PRODUCT: ORAL-B BRUSHHEADS, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    (PIERCED THE SKIN AND) DREW BLOOD [SKIN HAEMORRHAGE]; STABBED HIM IN THE CHEEK, IT PIERCED THE SKIN [SKIN INJURY]; HEAD CAME SEPARATED FROM THE UNIT AND THE POINTED END STABBED HIM IN THE CHEEK IT PIERCED THE SKIN AND DREW BLOOD - ORAL-B TOOTHBRUSH [INJURY ASSOCIATED WITH DEVICE]; ORAL-B BRUSHHEAD CAME SEPARATED FROM THE UNIT [DEVICE BREAKAGE]. CASE DESCRIPTION: A WIFE REPORTED VIA E-MAIL ON (B)(6) 2016 THAT WHEN HER HUSBAND, AGE UNSPECIFIED, PULLED AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN FROM HIS MOUTH ON AN UNSPECIFIED DATE, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN CAME SEPARATED FROM THE UNIT AND THE POINTED END STABBED HIM IN THE CHEEK. THE REPORTER STATED IT PIERCED THE SKIN AND DREW BLOOD. THE CASE OUTCOME WAS UNKNOWN. ON (B)(6) 2016 RECEIVED REPORTER'S FOLLOW-UP E-MAIL: THE WIFE REPORTED THAT HER HUSBAND USED AN ORAL-B PRO 600 RECHARGEABLE TOOTHBRUSH WITH AN ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN FROM A PACK OF 3. HE CHANGED HIS TOOTHBRUSH HEAD ABOUT EVERY 4 MONTHS, BUT THE REFILL HE HAD USED WAS NOT THAT OLD. SHE REPORTED THE BRUSH HAS NEVER BEEN DROPPED BUT MAY HAVE FALLEN FROM UPRIGHT. THE CASE OUTCOME REMAINED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17721 ORALBPWRRCHGTOOTHBRUSHHANDLEPROCROSSACTN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD EB20 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 ORAL-B PRO 600 RECHARGEABLE TOOTHBRUSH