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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756; TOOTHBRUSH, POWERED - JEQ
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number 3756
Device Problem Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
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
Electric shock went up arm.[electric shock].Malfunction hazard/electric shock - oral-b.[device inappropriate shock delivery].Electric shock off toothbrush when plugged the plug into the socket - oral-b.[device physical property issue].Case narrative: consumer via phone stated that they got an electric shock up their arm off their oral-b toothbrush, type 3756, when they plugged it into the socket.No serious injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3756
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)
UNSPECIFIED MANUFACTURER
unspecified address
unspecified city
Manufacturer Contact
mgr. affairs, oral care-see co
mason business center 8700 ma
son-montgomery rd
mason 45040
MDR Report Key16239702
MDR Text Key308416598
Report Number3000302531-2023-00040
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 01/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3756
Device Lot Number1 CB03331537
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 Unknown
Patient Sequence Number1
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