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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS; TOOTHBRUSH, POWERED
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS; TOOTHBRUSH, POWERED Back to Search Results
Model Number 3765
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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
Consumer reported via phone the plastic where you put the brush head on toothbrush cracked and the brush head falls off.No injury was reported.
 
Event Description
Consumer reported via phone the plastic where you put the brush head on toothbrush cracked and the brush head falls off.No injury was reported.
 
Manufacturer Narrative
07-jul-21: product return was received and investigated.Product investigation results showed that the complaint is caused by a breakage of the tip of the driving shaft due to improper consumer handling, storing and cleaning of the product.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key11725178
MDR Text Key249769344
Report Number3000302531-2021-00158
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 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3765
Device Lot NumberBC704130834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORALBPWRPWRORALCARERFLSCROSSACTNEB50; ORALBPWRPWRORALCARERFLSCROSSACTNEB50; ORALBPWRPWRORALCARERFLSSEN; ORALBPWRPWRORALCARERFLSSENSIULTRATHINEB60
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