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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B BRUSHHEADS, VERSION UNKNOWN; TOOTHBRUSH, POWERED - JEQ
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BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B BRUSHHEADS, VERSION UNKNOWN; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Laceration(s) (1946); Pain (1994)
Event Type  malfunction  
Manufacturer Narrative
Product return was requested or its in transport.Evaluation will occur upon receipt of product return.
 
Event Description
Cut mouth [mouth injury].Bruise mouth [oral contusion].Painfully - mouth [oral pain].Brushes will no longer stay on the toothbrush - oral-b [device breakage].Case narrative: consumer via e-mail stated that the oral-b toothbrush refills no longer stayed on the oral-b toothbrush whilst they were cleaning their teeth.When the oral-b toothbrushes fly off, they often bruise or even cut their mouth, which is painful.No serious injury was reported.
 
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Brand Name
ORAL-B BRUSHHEADS, VERSION UNKNOWN
Type of Device
TOOTHBRUSH, POWERED - JEQ
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld D-978 28
GM  D-97828
Manufacturer (Section G)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld D-978 28
GM   D-97828
Manufacturer Contact
mgr. affairs, oral care-see co
mason business center 8700 ma
son-montgomery rd
mason 45040
MDR Report Key16833371
MDR Text Key314276577
Report Number3000302531-2023-00168
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (O
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