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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 No Consequences Or Impact To Patient (2199)
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
Consumer contacted via e-mail and stated that one of the two brushes on his/her dual clean brush became detached in his/her mouth.No injury was reported.
 
Event Description
Consumer contacted via e-mail and stated that one of the two brushes on his/her dual clean brush became detached in his/her mouth.No injury was reported.
 
Manufacturer Narrative
Product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.
 
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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 Key9503252
MDR Text Key191197951
Report Number3000302531-2019-00232
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
Type of Report Initial,Followup
Report Date 11/24/2019
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 11/24/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received12/23/2019
Supplement Dates FDA Received01/21/2020
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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