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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT; TOOTHBRUSH, POWERED
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT; TOOTHBRUSH, POWERED Back to Search Results
Model Number EB417
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Choking (2464)
Event Type  malfunction  
Manufacturer Narrative
Product return was received and product investigation is in progress.
 
Event Description
Choke [choking].The round brush completely detached from the head [device breakage].Case description: consumer reported via e-mail that the round brush completely detached from the brush head while brushing.No serious injury was reported.
 
Manufacturer Narrative
20-jan-2020 product investigation results: product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.
 
Event Description
Choke [choking], the round brush completely detached from the head [device breakage], product counterfeit [product counterfeit].Consumer reported via e-mail that the round brush completely detached from the brush head while brushing.No serious injury was reported.
 
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Brand Name
ORALBPWRPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key9530940
MDR Text Key191197990
Report Number3000302531-2019-00237
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberEB417
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Initial Date Manufacturer Received 12/03/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/20/2020
Supplement Dates FDA Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
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