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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
Model Number 4729
Device Problems Break (1069); Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Male consumer via e-mail stated that last week he became aware of an alarming burnt smell in the morning.He was surprised to discover that the battery for his oral-b electric toothbrush (that he has been using for years) had exploded.No serious injury was reported.
 
Manufacturer Narrative
This report is being filed as an battery of an oral-b oscillating/rotating rechargeable toothbrush allegedly exploded while not in use.This report is being filled out of an abundance of caution.Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Male consumer via e-mail stated that last week he became aware of an alarming burnt smell in the morning.He was surprised to discover that the battery for his oral-b electric toothbrush (that he has been using for years) had exploded.No serious injury was reported.
 
Manufacturer Narrative
07-feb-2022, product investigation results: product return was received and investigated.Investigation results confirmed that the melted area on housing of the handle has been caused by a short circuit overheating the pcb/motor transistor.
 
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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
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 Key12814112
MDR Text Key282115601
Report Number3000302531-2021-00363
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 Foreign,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/16/2021
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 Model Number4729
Device Lot NumberF64941021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/16/2021
Initial Date FDA Received11/15/2021
Supplement Dates Manufacturer Received02/07/2022
Supplement Dates FDA Received03/04/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
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