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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLS3DWHITEEB18; TOOTHBRUSH, POWERED
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLS3DWHITEEB18; TOOTHBRUSH, POWERED Back to Search Results
Model Number EB18
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); Choking (2464); Unspecified Tissue Injury (4559)
Event Type  malfunction  
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Cheeks bleed- mouth [mouth haemorrhage].Lip bleed [lip haemorrhage].Caught lip [lip injury].Caught cheeks- mouth [mouth injury].Nearly choke [choking sensation].Loose heads - brush head [device physical property issue].Complete detachment of the head- brush head [device breakage].Case description: consumer sent e-mail stating the brush heads had loose heads, and the head completely detached from a brush head.No serious injury was reported.
 
Event Description
Cheeks bleed- mouth [mouth haemorrhage].Lip bleed [lip haemorrhage].Caught lip [lip injury].Caught cheeks- mouth [mouth injury].Nearly choke [choking sensation].Loose heads - brush head [device physical property issue].Complete detachment of the head- brush head [device breakage].Product counterfeit [product counterfeit].Case description: consumer sent e-mail stating the brush heads had loose heads, and the head completely detached from a brush head.No serious injury was reported.
 
Manufacturer Narrative
22-jan-2021 product investigation results: 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
ORALBPWRPWRORALCARERFLS3DWHITEEB18
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key10454160
MDR Text Key227763914
Report Number3000302531-2020-00148
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 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberEB18
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Date Manufacturer Received01/22/2021
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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