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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEAN; TOOTHBRUSH, POWERED
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEAN; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Product return was not received.Product return was requested.Full evaluation will occur upon receipt of returned product.
 
Event Description
Loose brush head into throat [foreign body in respiratory tract].Coughing [cough].Toothbrush head shot off [device breakage].Case description: consumer reported via e-mail that the brush head shot off while he was brushing his teeth.No serious injury was reported.
 
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Brand Name
ORALBPWRPWRORALCARERFLSPRECISIONCLEAN
Type of Device
TOOTHBRUSH, POWERED
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
regulatory oral care
8700 mason-montgomery rd
mason, OH 45040
MDR Report Key9582497
MDR Text Key191198068
Report Number3000302531-2020-00015
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2019
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
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