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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE4729JRJUNIORMODELD16.513.1; TOOTHBRUSH, POWERED - JEQ
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE4729JRJUNIORMODELD16.513.1; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number D16.513.1
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
Event Type  malfunction  
Event Description
Bled - mouth [mouth haemorrhage].Injured - mouth [mouth injury].Brush heads are no longer staying securely attached - oral-b [device breakage].Case narrative: a parent via phone stated that the oral-b toothbrush heads were no longer staying securely attached to the oral-b junior purple.As a result, their daughter injured herself and it bled.No serious injury was reported.
 
Manufacturer Narrative
Complained product will not be not available.
 
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Brand Name
ORALBRCHGTOOTHBRUSHHANDLE4729JRJUNIORMODELD16.513.1
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)
UNSPECIFIED MANUFACTURER
unspecified address
unspecified city
Manufacturer Contact
mgr. affairs, oral care-see co
mason business center 8700 ma
son-montgomery rd
mason 45040
MDR Report Key18221010
MDR Text Key329921307
Report Number3000302531-2023-00488
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeGM
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 11/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberD16.513.1
Was Device Available for Evaluation? No
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
ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL
Patient SexFemale
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