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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSFLOSSACTNEB25BRUSHSET4CT; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSFLOSSACTNEB25BRUSHSET4CT; TOOTHBRUSH, POWERED Back to Search Results
Model Number EB25
Device Problems Break (1069); Separation Problem (4043)
Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)
Event Type  malfunction  
Manufacturer Narrative
The reporter informed the company that the product had been discarded.
 
Event Description
Catching skin inside mouth, cheek [mouth injury]; bleed - cheek [mouth haemorrhage]; brush head separated in two, broke [device breakage]; the space between the round head and the arm it was attached to had got wider [device physical property issue]; consumer e-mailed and stated that the whole brush head separated in two, it broke.No serious injury was reported.
 
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Brand Name
ORALBPWRPWRORALCARERFLSFLOSSACTNEB25BRUSHSET4CT
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 Key8757437
MDR Text Key151124217
Report Number3000302531-2019-00113
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeUK
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 06/07/2019
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 NumberEB25
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/07/2019
Initial Date FDA Received07/03/2019
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 Reuse
Patient Sequence Number1
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