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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE4729; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE4729; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)
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 e-mail that brushheads were loose and fell out of toothbrush during use.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE4729
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key12440012
MDR Text Key271726553
Report Number3000302531-2021-00297
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
Report Date 08/16/2021
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 08/16/2021
Initial Date FDA Received09/08/2021
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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