BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 7421399 · Received April 11, 2018

    Report

    Report Number
    3000302531-2018-00101
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Report Date
    March 16, 2018
    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 · 0

    20-APR-2018 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED AN UNSPECIFIED NUMBER OF TOOTHBRUSH HEADS ON 20-APR-2018. TOOTHBRUSH HEADS CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 0

    REPORT SOURCE: NON-EVENT - SPONTANEOUS. A MALE CONSUMER OF UNSPECIFIED AGE REPORTED VIA E-MAIL ON 16-MAR-2018 THAT HIS ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN CAME APART IN HIS MOUTH WHILE HE WAS CLEANING HIS TEETH WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. HE ELABORATED THAT THE HEAD CAME OFF AND A SMALL 4-5 MILLIMETER ROUND PIECE OF METAL WAS LEFT PROTRUDING. THIS WAS THE FIRST TIME THAT HE HAD EXPERIENCED THIS IN MANY YEARS OF USING AN ELECTRIC TOOTHBRUSH, AND HE HAD KEPT THE PARTS. NO SYMPTOMS DEVELOPED. RELEVANT HISTORY: NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    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 RETURNED PRODUCT.

    Description of Event or Problem · 1

    ORAL-B PRECISION CLEAN HEAD CAME APART IN MOUTH, THE HEAD CAME OFF AND A SMALL 4-5 MM ROUND PIECE OF METAL WAS LEFT PROTRUDING [DEVICE BREAKAGE] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE DESCRIPTION: REPORT SOURCE: NON-EVENT - SPONTANEOUS. A MALE CONSUMER OF UNSPECIFIED AGE REPORTED VIA E-MAIL ON (B)(6) 2018 THAT HIS ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN CAME APART IN HIS MOUTH WHILE HE WAS CLEANING HIS TEETH WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. HE ELABORATED THAT THE HEAD CAME OFF AND A SMALL 4-5 MILLIMETER ROUND PIECE OF METAL WAS LEFT PROTRUDING. THIS WAS THE FIRST TIME THAT HE HAD EXPERIENCED THIS IN MANY YEARS OF USING AN ELECTRIC TOOTHBRUSH, AND HE HAD KEPT THE PARTS. NO SYMPTOMS DEVELOPED. RELEVANT HISTORY: NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265421 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN| ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN