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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPH; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPH; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problems Device Fell (4014); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The reporter informed the company that the product has been discarded.
 
Event Description
Consumer via phone stated that the brush head kept falling off their old toothbrush in their mouth.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPH
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 Key11748900
MDR Text Key250427709
Report Number3000302531-2021-00165
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeGM
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 04/21/2021
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 Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received04/29/2021
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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