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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3753IO6SRSM6MODELIOM6D.2J6; TOOTHBRUSH, POWERED - JEQ

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3753IO6SRSM6MODELIOM6D.2J6; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number IOM6D.2J6
Device Problems Fire (1245); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This report is being filed due to an alleged fire event.This report is being filled out of an abundance of caution.The reporter informed the company that the product has been discarded.
 
Event Description
Photo of fire event - oral-b [device catching fire].Toothbrushes don't work well like it use to when we 1st used it the battery lasts maybe for 3 days only then we have to charge it again - oral-b [device physical property issue].Case narrative: a spouse via social media submit pictures showing a fire event caused by their wife's oral-b io6 pink sand toothbrush.They also reported that it did not work well like it used to when she first used it, as the battery only lasted for maybe three days before it needed charged again.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3753IO6SRSM6MODELIOM6D.2J6
Type of Device
TOOTHBRUSH, POWERED - JEQ
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
mgr. affairs, oral care-see co
mason business center 8700
mason-montgomery rd
mason 45040
MDR Report Key14344904
MDR Text Key293855236
Report Number3000302531-2022-00183
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIOM6D.2J6
Device Lot NumberAM13951703
Was Device Available for Evaluation? No
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
Patient SexFemale
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